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Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03809988

{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\nAdvanced Breast Cancer\nHormone Receptor Positive Tumor\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1"}

{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03809988

{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\r\nAdvanced Breast Cancer\r\nHormone Receptor Positive Tumor\r\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1"}

{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04158440

{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}

{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04158440

{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}

{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02853331

{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02853331

{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04744831

{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}

{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04744831

{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}

{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04334941

{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': "This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}

{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04334941

{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': "This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}

{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Biliary Tract Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Bladder Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Ovarian Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Pancreatic Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Rare Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03635567

{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}

{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03635567

{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}

{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03907488

{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age &gt;/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03907488

{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age &gt;/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03391466

{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}

{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03391466

{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}

{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03936270

{'Official Title': 'Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.', 'Brief Summary': 'The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Letrozole (Femara®) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance®) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13.\n\nBased on the results of phase 1 and 2 clinical trials of CDK4/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER/PR expression, its combination with Letrozole can improve outcomes in ER/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.', 'Inclusion Criteria': "Inclusion Criteria:\n\nEvidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;\nSubject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n18 years of age or older;\nPatient agrees not to participate in another interventional study while on treatment;\nHistology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic;\nEstrogen (ER) and/or progesterone (RP) receptor positive tumor, defined as > 10% by immunohistochemical examination in the local laboratory;\nAvailability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and/or RP in a central laboratory;\nDisease measurable by RECIST 1.1 as assessed by the local investigator or radiologist;\nPatients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria:\n\nat least one platinum-based chemotherapy regimen;\nhave confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease\nPatient must have radiographic disease progression to last treatment;\nFunctional capacity by the Eastern Cooperative Oncology Group (ECOG) ≤ 2;\nAdequate bone marrow function:\n\nAbsolute neutrophil count (CAN) ≥ 1,500/mm3 (≥ 1.5x109/L)\nPlates ≥ 100,000/mm3 or ≥ 100 x 109/L\nHemoglobin ≥ 9.0 g/dL;\n12. Adequate liver function:\n\nTotal serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if there is Gilbert's Syndrome)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN if liver tumor was involved)\nAlkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function:\nEstimated creatinine clearance ≥ 15 mL/min; 14. Evidence of lack of potential to become pregnant:\nPost-menopause (defined as at least 1 year without menstruation) before selection, or\nRadiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or\nSurgical sterilization (bilateral oophorectomy or hysterectomy)."}

{'Arm - Disease - Indication': 'PR-Positive ER-Positive Previously Treated Metastatic High Grade Serous Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Endometrioid Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Fallopian Tube Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Locoregionally Recurrent Peritoneal Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04626791

{'Official Title': 'A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma', 'Brief Summary': 'This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.', 'Condition': 'Mantle Cell Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To determine the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate the safety of this regimen. II. To determine the proportion of subjects proceeding to autologous stem cell transplant (ASCT).\r\n\r\nIII. To determine the feasibility and results of stem cell mobilization and successful collection.\r\n\r\nIV. To determine the progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration.\r\n\r\nCORRELATIVE RESEARCH OBJECTIVE:\r\n\r\nI. To assess minimal residual disease level after 3 and 6 cycles of therapy using the ClonoSEQ (Adaptive Biotechnologies, Seattle, Washington [WA]), and to explore the relationship between radiographic complete response (CR) rate and baseline features.\r\n\r\nOUTLINE:\r\n\r\nCYCLES 1, 3, AND 5: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-21. Patients also receive bortezomib subcutaneously (SC) on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) intravenously (IV), cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5.\r\n\r\nCYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2.\r\n\r\nTreatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for up to 2 years after registration.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge 18-75 years\r\nNo prior therapy for mantle cell lymphoma (MCL)\r\nMCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician\r\nDocumented histological confirmation of MCL by local institutional review\r\nDocumented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length\r\nEastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2\r\nAbsolute neutrophil count (ANC) >= 1000/mm^3 or >= 500/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nPlatelet count >= 100,000/mm^3 or >= 75,000/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained =< 30 days prior to registration)\r\nAspartate transaminase (AST) =< 3 x ULN (obtained =< 30 days prior to registration)\r\nProthrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) =< 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =< 30 days prior to registration)\r\nCalculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula (obtained =< 30 days prior to registration)\r\nNegative pregnancy test done within =< 14 days prior to registration for women of childbearing potential only\r\nFor women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group [CTFG] as having a failure rate of < 1% per year\r\nMen must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy\r\nProvide informed written consent\r\nWilling to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\r\nHematologic labs must be obtained within =< 14 days of registration\r\nWilling and able to participate in all required evaluations and procedures in this study protocol\r\nAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information"}

{'Arm - Disease - Indication': 'First-Line Mantle Cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03627728

{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}

{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03627728

{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}

{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04590599

{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}

{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04590599

{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}

{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05608785

{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}

{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05608785

{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}

{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05608785

{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}

{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03505554

{'Official Title': 'A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)', 'Brief Summary': 'The purpose of this study is to define the objective response rates (ORR) of Lorlatinib in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.', 'Condition': 'Anaplastic Large Cell Lymphoma, ALK-Positive', 'Detailed Description': 'Lorlatinib is a selective and potent tyrosine kinase inhibitor of ALK and ROS1 that pre-clinically demonstrated dose-dependent inhibition of mutations that confer resistance to other ALK inhibitors; it is also a brain-penetrant thus it might be active in patients with CNS metastases.\r\n\r\nStudy Objectives Primary Define the objective response rates (ORR) of PF-06463922 in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.\r\n\r\nSecondary\r\n\r\nDefine the Progression Free Survival (PFS) in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.\r\nDefine the overall survival (OS) in ALK+ lymphoma patients treated with Lorlatinib, that are resistant or refractory to ALK inhibitors.\r\nDetermine the toxicity profile of Lorlatinib in ALK+ lymphoma patients resistant or refractory to ALK inhibitors.\r\nDetermine the Quality of Life (QoL) in this population of patients using the EORTC-C30 Quality of Life questionnaire.\r\nStudy the mutational status of ALK pre/post Lorlatinib treatment through next-generation sequencing (NGS).\r\nStudy design This is a phase 2 study open to 12 eligible patients with lymphoma with a confirmed ALK rearrangement. All patients must have been pretreated with at least one line of standard cytotoxic chemotherapy and at least one ALK inhibitor and they must have demonstrated progression (regardless of initial response) or resistance on the last treatment.\r\n\r\nThe study begins with a screening period to assess eligibility, up to and including 28 days prior to the first dose of Lorlatinib. Treatment will continue until patient experiences unacceptable toxicity or progressive disease (PD), starts a new anti-cancer therapy or dies.\r\n\r\nThe study will remain open until all patients have completed 3 years from the enrollment.\r\n\r\nStudy treatment Patients will receive an oral administration of Lorlatinib at a dose of 100mg QD. In case of toxicity, it is possible to proceed to a dose reduction (75mg or 50mg QD) or a temporary interruption of Lorlatinib.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nSigned and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.\r\nALK+ Lymphoma diagnosed by IHC or FISH.\r\nRefractory disease or relapse after at least one prior chemotherapy regimen (typically a minimum of 6 cycles of CHOP) and at least one ALK inhibitor; presence of measurable disease by physical examination, CT or CT-PET scan.\r\nAny prior antitumor medical treatment or major surgeries must have been completed at least 14 days prior to initiation of study medication. This could not be respected if there is clear evidence of disease progression, manifested as growing pain attributable to the tumour, fever, growing tumour lesions, increasing LDH values. Systemic anti-cancer therapy completed within a minimum of 5 half-lives of study entry.\r\nAble to take oral therapy.\r\nFemale or male, 18 years of age or older.\r\nECOG performance status 0-3.\r\nAdequate organ function as defined by the following criteria:\r\n\r\nSerum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin 1.5 x ULN (except patients with documented Gilbert's syndrome Creatinine ≤ 1.5 x ULN.\r\n\r\nAdequate bone marrow function:\r\n\r\nAbsolute neutrophil count (ANC) ≥ 1000/µL Platelets ≥ 50.000/µL Hemoglobin ≥ 9.0 g/dL The hematological values will not be considered in case of bone marrow involvement.\r\n\r\nWillingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\r\nFemale and male patients who are of childbearing potential must agree to use an effective form of contraception (2 forms of contraception) with their partners throughout participation in this study and for at least 90 days after the last dose of treatment."}

{'Arm - Disease - Indication': 'Relapsed ALK Positive Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05715840

{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy)."}

{'Arm - Disease - Indication': 'Recurrent, or Metastatic PD-L1 Positive Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05715840

{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy)."}

{'Arm - Disease - Indication': 'Recurrent, or Metastatic PD-L1 Positive Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05529667

{'Official Title': 'An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.', 'Brief Summary': 'This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.', 'Condition': 'Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel', 'Detailed Description': 'phase>\r\n\r\n- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle.\r\n\r\nphase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients who agreed in writing to the clinical study consent\r\nHistologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.\r\nFGFs / FGFRs have genetic variation on NGS.\r\nPatients whose life expectancy is at least 3 months\r\nIf the Eastern Cooperative Oncology Group (ECOG) is 0 or 1\r\nMeasurable or assessable lesion based on RECIST 1.1 scale\r\nMust be swallowed, should be able to take oral medication\r\nPossible long-term function to receive chemotherapy.\r\nPatients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment'}

{'Arm - Disease - Indication': 'Second-Line Progressive or Advanced or Recurrent FGF Aberrated or FGFR Aberrated Gastric Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥18 years at the time of screening and female.\r\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\r\nPatient must have endometrial cancer in one of the following categories:\r\n\r\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\r\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\r\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\r\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\r\nFPPE tumor sample must be available for MMR evaluation.\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03617679

{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': "Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nProvision to sign and date the consent form.\nStated willingness to comply with all study procedures and be available for the duration of the study.\nBe a female aged 18-89.\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\nECOG performance status of 0, 1 or 2.\nANC > or = 1500 cells/microliters\nPlatelet count > 100,000 microliters\nHemoglobin > or = 9.0 g/dL\nSerum albumin > or = 2.5 g/dL\nTotal bilirubin ≤ 1.5 x ULN\nAST and ALT ≤ 3.0 x ULN\nSerum Creatinine ≤ 1.5x ULN"}

{'Arm - Disease - Indication': 'First line Primary Stage III/IV or Recurrent Metastatic Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03617679

{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\r\n\r\nProvision to sign and date the consent form.\r\nStated willingness to comply with all study procedures and be available for the duration of the study.\r\nBe a female aged 18-89.\r\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\r\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\r\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\r\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\r\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\r\nECOG performance status of 0, 1 or 2.\r\nANC > or = 1500 cells/microliters\r\nPlatelet count > 100,000 microliters\r\nHemoglobin > or = 9.0 g/dL\r\nSerum albumin > or = 2.5 g/dL\r\nTotal bilirubin ≤ 1.5 x ULN\r\nAST and ALT ≤ 3.0 x ULN\r\nSerum Creatinine ≤ 1.5x ULN"}

{'Arm - Disease - Indication': 'First line Primary Stage III/IV or Recurrent Metastatic Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05422911

{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}

{'Arm - Disease - Indication': 'First-Line Castrate-sensitive Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05422911

{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\r\n\r\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}

{'Arm - Disease - Indication': 'First-Line Castrate-sensitive Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\n\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\nMaintenance therapy will not be counted as a separate line of systemic therapy.\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\nAdequate bone marrow function at screening, defined as:\n\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\nAdequate liver and kidney function, defined as:\n\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\nAn estimated life expectancy of >3 months at Screening.\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04442022

{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}

{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04934722

{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}

{'Arm - Disease - Indication': 'Metastatic Hormone-Sensitive Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04934722

{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}

{'Arm - Disease - Indication': 'Metastatic Hormone-Sensitive Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05201352

{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\r\n\r\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms."}

{'Arm - Disease - Indication': 'Previously Treated Metastatic Colorectal Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05201352

{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\n\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms."}

{'Arm - Disease - Indication': 'Previously Treated Metastatic Colorectal Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03875235

{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}

{'Arm - Disease - Indication': 'First-Line Previously Untreated Unresectable Advanced or Metastatic Biliary Tract Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03875235

{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}

{'Arm - Disease - Indication': 'First-Line Previously Untreated Unresectable Advanced or Metastatic Biliary Tract Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01972217

{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}

{'Arm - Disease - Indication': 'Previously Treated Metastatic Castration-Resistant Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01972217

{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}

{'Arm - Disease - Indication': 'Previously Treated Metastatic Castration-Resistant Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05797831

{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}

{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01120249

{'Official Title': 'EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study', 'Brief Summary': 'RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.\r\n\r\nPURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.', 'Condition': 'Kidney Cancer', 'Detailed Description': 'OBJECTIVES:\r\n\r\nPrimary\r\n\r\nto compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.\r\nSecondary\r\n\r\nTo compare the overall survival of patients treated with everolimus vs placebo.\r\nTo compare qualitative and quantitative toxicity between the two study arms.\r\nTo bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.\r\nTo bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.\r\nOUTLINE: This is a multicenter study.\r\n\r\nPatients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.\r\n\r\nArm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArchived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.', 'Inclusion Criteria': 'DISEASE CHARACTERISTICS:\r\n\r\nHistologically or cytologically confirmed renal cell carcinoma\r\n\r\nClear cell or non-clear cell allowed\r\n\r\nNo disease of the collecting duct or medullary carcinoma\r\nConsidered pathologically either intermediate high-risk or very high-risk disease\r\nNo history of distant metastases\r\nPatients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible\r\nHave undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes\r\n\r\nSurgical margins must be negative\r\n\r\nPatients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)\r\nPatients must be registered within 84 days after the date of the first surgical resection of the first tumor\r\nNo evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration\r\n\r\nMRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast\r\nPATIENT CHARACTERISTICS:\r\n\r\nZubrod performance status 0-1\r\nANC ≥ 1,500/mm^3\r\nPlatelet count ≥ 100,000/mm^3\r\nSerum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min\r\nBilirubin ≤ 1.5 times ULN\r\nSGOT and SGPT ≤ 2.5 times ULN\r\nNot pregnant or nursing\r\nFertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment\r\nAble to take oral medications\r\nPatients must not have any of the following:\r\n\r\nNYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)\r\nUnstable angina pectoris\r\nMyocardial infarction within the past 6 months\r\nSerious uncontrolled cardiac arrhythmia\r\nPatients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)\r\nHBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection\r\nMust be able to take oral medications\r\nNo impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\nNo known history of HIV seropositivity\r\nNo known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)\r\nNo uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration\r\n\r\nOptimal lipid control must be achieved before registration and monitored during protocol treatment\r\nNo uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.\r\n\r\nOptimal glucose control must be achieved before registration and monitored during protocol treatment\r\nNo prior malignancies except for any of the following:\r\n\r\nAdequately treated basal cell or squamous cell skin cancer\r\nIn situ cervical cancer\r\nAdequately treated stage I or stage II cancer from which the patient is currently in complete remission\r\nAny other cancer from which the patient has been disease-free for 5 years\r\nNo known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients\r\nNo contraindications to receiving either IV iodine-based contrast or gadolinium\r\nPRIOR CONCURRENT THERAPY:\r\n\r\nSee Disease Characteristics\r\nPatients must have recovered from any surgery-related complications\r\nNo prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy\r\nMore than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)\r\nMore than 7 days since prior and no concurrent live vaccines\r\nNo other concurrent anticancer agents including investigational agents\r\nNo concurrent chronic treatment with systemic steroids or another immunosuppressive agent\r\n\r\nTopical or inhaled corticosteroids are allowed'}

{'Arm - Disease - Indication': 'Intermediate high-risk or very high-risk Postoperative Renal Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01120249

{'Official Title': 'EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study', 'Brief Summary': 'RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.\r\n\r\nPURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.', 'Condition': 'Kidney Cancer', 'Detailed Description': 'OBJECTIVES:\r\n\r\nPrimary\r\n\r\nto compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.\r\nSecondary\r\n\r\nTo compare the overall survival of patients treated with everolimus vs placebo.\r\nTo compare qualitative and quantitative toxicity between the two study arms.\r\nTo bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.\r\nTo bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.\r\nOUTLINE: This is a multicenter study.\r\n\r\nPatients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.\r\n\r\nArm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArchived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.', 'Inclusion Criteria': 'DISEASE CHARACTERISTICS:\r\n\r\nHistologically or cytologically confirmed renal cell carcinoma\r\n\r\nClear cell or non-clear cell allowed\r\n\r\nNo disease of the collecting duct or medullary carcinoma\r\nConsidered pathologically either intermediate high-risk or very high-risk disease\r\nNo history of distant metastases\r\nPatients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible\r\nHave undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes\r\n\r\nSurgical margins must be negative\r\n\r\nPatients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)\r\nPatients must be registered within 84 days after the date of the first surgical resection of the first tumor\r\nNo evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration\r\n\r\nMRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast\r\nPATIENT CHARACTERISTICS:\r\n\r\nZubrod performance status 0-1\r\nANC ≥ 1,500/mm^3\r\nPlatelet count ≥ 100,000/mm^3\r\nSerum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min\r\nBilirubin ≤ 1.5 times ULN\r\nSGOT and SGPT ≤ 2.5 times ULN\r\nNot pregnant or nursing\r\nFertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment\r\nAble to take oral medications\r\nPatients must not have any of the following:\r\n\r\nNYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)\r\nUnstable angina pectoris\r\nMyocardial infarction within the past 6 months\r\nSerious uncontrolled cardiac arrhythmia\r\nPatients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)\r\nHBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection\r\nMust be able to take oral medications\r\nNo impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\nNo known history of HIV seropositivity\r\nNo known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)\r\nNo uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration\r\n\r\nOptimal lipid control must be achieved before registration and monitored during protocol treatment\r\nNo uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.\r\n\r\nOptimal glucose control must be achieved before registration and monitored during protocol treatment\r\nNo prior malignancies except for any of the following:\r\n\r\nAdequately treated basal cell or squamous cell skin cancer\r\nIn situ cervical cancer\r\nAdequately treated stage I or stage II cancer from which the patient is currently in complete remission\r\nAny other cancer from which the patient has been disease-free for 5 years\r\nNo known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients\r\nNo contraindications to receiving either IV iodine-based contrast or gadolinium\r\nPRIOR CONCURRENT THERAPY:\r\n\r\nSee Disease Characteristics\r\nPatients must have recovered from any surgery-related complications\r\nNo prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy\r\nMore than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)\r\nMore than 7 days since prior and no concurrent live vaccines\r\nNo other concurrent anticancer agents including investigational agents\r\nNo concurrent chronic treatment with systemic steroids or another immunosuppressive agent\r\n\r\nTopical or inhaled corticosteroids are allowed'}

{'Arm - Disease - Indication': 'Intermediate high-risk or very high-risk Postoperative Renal Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04634877

{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization."}

{'Arm - Disease - Indication': 'Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04634877

{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization."}

{'Arm - Disease - Indication': 'Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02043678

{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}

{'Arm - Disease - Indication': 'Asymptomatic or Mild Symptomatic Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer\nSecondary Bone Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02043678

{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}

{'Arm - Disease - Indication': 'Asymptomatic or Mild Symptomatic Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer\r\nSecondary Bone Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05319249

{'Official Title': 'Natural Killer Cell Immunotherapy in Combination With PARP-inhibition to Overcome NKG2D Mediated Immune Evasion in Acute Myeloid Leukemia', 'Brief Summary': 'Therapy resistance remains the major obstacle to cure in many types of cancer. In particular in leukemia, therapy resistance depends on leukemic stem cells (LSC) that exhibit inherent therapy resistance to multiple drugs and contribute to overt leukemic relapse. Cellular therapies alone or in combination with other targeted or chemotherapeutic approaches can overcome drug mediated therapy resistance and induce long lasting remissions. Several trials have shown that adoptive transfer of allogeneic NK cells can induce clinical remission in patients with myeloid malignancies. In addition, the antileukemic efficacy of alloreactive NK cells has been shown to facilitate cure after T cell depleted haploidentical stem cell transplantation. Recently, it was demonstrated that absence of NKGD2 ligand expression on leukemic stem cells determines therapy resistance and immune escape towards NK cells in AML. PARP1 inhibitors can induce re-expression of NKG2D ligands. This phase I/II clinical trial will evaluate the combination of NK cell therapy and PARP inhibition by Talazoparib in patients with poor prognosis AML as characterized by Minimal Residual Disease (MRD) or overt relapse with less than 20% bone marrow blasts. The hypothesis that allogeneic NK cell therapy combined with PARP inhibition will increase the response rate (CR/CRi for relapsed/ refractory patients and MRD-response for MRD positive patients) from 35% to 60% will be tested. The co-primary endpoints are i) response to treatment defined as complete remission (CR) for patients with overt leukemia at time of inclusion and MRD decrease >1log10 for patients with rising MRD at time of inclusion as well as ii) safety and feasibility of the protocol. Key secondary endpoints are event free survival and overall survival. Two cohorts will be assessed independently: patients with i) overt leukemia and ii) patients with rising MRD at time of inclusion. Safety and feasibility will be analyzed continuously during the entire trial. The NAKIP-AML trial will analyze efficacy and feasibility of NK cell transplantation together with PARP1 inhibition.', 'Condition': 'Acute Myeloid Leukemia', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients with confirmed diagnosis of AML according to WHO-2016 (Arber, Orazi et al. 2016) (except acute promyelocytic leukemia) with either de novo AML, AML after preceding myelodysplastic or myeloproliferative syndrome (MDS/MPD), and therapy- related AML (t-AML) after previous cytotoxic therapy or radiation are eligible.\r\n\r\nA) Relapsed or Refractory AML with less than 20% bone marrow blasts and less than 20% blasts in peripheral blood.\r\n\r\nB) Rising MRD levels (>3 fold) as detected by either molecular genetics or flow cytometry in patients still in hematologic remission.\r\n\r\nPatients who received at least one line of AML therapy. This is defined as either stem cell transplantation or intensive AML therapy or palliative AML therapy containing at least one of the following drugs Azacitidine, Decitabine, Cytarabine, Venetoclax or an FLT3 inhibitor..\r\nDiscontinuation of prior AML treatment before the start of study treatment for at least 107 days for cytotoxic agents and ≥ 53 half-lives for non-cytotoxic / investigational drug treatment preceding the first dose of trial medications.\r\nAge ≥ 18 years\r\nECOG ≤2\r\nPregnancy and childbearing potential:\r\n\r\nNon-pregnant and non-nursing women of childbearing potential must have a negative serum or urine ß-HCG pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration. ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).\r\nFemale patients of reproductive age must agree to avoid getting pregnant while on therapy.\r\nWomen of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin highly effective methods (referring to recommendation of the CTFG) of birth control during study and at least 6 months (women), after end of treatment.\r\nMen must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child during study and until 6 months after end of treatment.\r\nWillingness of patients to adhere to protocol specific requirements and capacity to give written informed consent\r\nAbility of patient to understand the character and individual consequences of clinical trial\r\nFollowing receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.\r\nSuitable donor for NK cell transplantation'}

{'Arm - Disease - Indication': 'Relapsed or Refractory Acute Myeloid Leukemia'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01068249

{'Official Title': 'A Phase II Study of Letrozole and RAD001 (Everolimus) in Patients With Advanced or Recurrent Endometrial Cancer', 'Brief Summary': 'The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.', 'Condition': 'Endometrial Cancer', 'Detailed Description': 'The Study Drugs:\r\n\r\nEverolimus is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.\r\n\r\nLetrozole is designed to block chemical pathways that are necessary for tumor growth.\r\n\r\nStudy Drug Administration:\r\n\r\nIf you are found to be eligible to take part in this study, you will take 2 pills of everolimus by mouth 1 time every day. You should not open everolimus until you are about to take it because it absorbs moisture and is sensitive to light. You will also take 1 pill of letrozole by mouth 1 time every day. You should take letrozole at the same time as everolimus.\r\n\r\nEverolimus should be taken the same time every day on an empty stomach (fasting state) or after no more than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not fat-free meal) before taking everolimus. You should not eat fatty foods for at least 1 hour after taking everolimus.\r\n\r\nIf you cannot swallow the tablets, the tablets should be dissolved in a glass of about 2 tablespoons of water just before being taken. The tablets should then be stirred gently (for a maximum of 7 minutes) until the tablets are dissolved. The contents should then be drunk. If you vomit after taking the study drug, you should not take another tablet that day. If you forgot to take the drug one day, you should not take an extra dose the next day but instead contact your doctor for advice.\r\n\r\nYou will be given a diary where you will record the pills you take each day. You must bring this diary to each visit.\r\n\r\nWhile you are on study, you should avoid grapefruit, grapefruit juice, and other products containing grapefruit. There are also certain drugs you cannot take during this study. You should not take any drugs during the study without asking the study doctor first.\r\n\r\nStudy Visits:\r\n\r\nEvery 4 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature).\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will asked about any side effects you have experienced.\r\nIf the disease is in the pelvis, you will have a pelvic exam.\r\nIf the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for hepatitis testing.\r\nYour pills will be counted.\r\nAt Week 8, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYou will asked about any side effects you have experienced.\r\nAfter the Week 8 Visit, you will have the following tests and procedures. (If the disease has partially or completely responded to the study drugs, these tests will be done around Week 12. If the disease is stable, these tests will be done around Week 16.)\r\n\r\nYou will have a physical exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT scan, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have a chest CT and/or MRI scan to check the status of the disease.\r\nAfter the Week 12 or 16 visit, every 12 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nI-f the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\n\r\nLength of Study:\r\n\r\nYou may continue receiving additional cycles of study treatment. You will be taken off study if you experience intolerable side effects, the disease gets worse, the disease completely responds, or the doctor thinks it is in your best interest.\r\n\r\nEnd of Treatment Visit:\r\n\r\nWithin 4 weeks after the last dose of study drugs, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYour pills will be counted and any unused study drug will be returned.\r\nLong Term Follow-up:\r\n\r\nAfter you are off study, you will be followed by your doctor on a regular basis. How often these visits occur are up to you and your doctor. The following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nYou will be asked if you have experienced any intolerable side effects.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nThis is an investigational study. Everolimus is not FDA approved or commercially available. At this time, everolimus is only being used in research. Letrozole is FDA approved and commercially available for the treatment of breast cancer and ovarian cancer. The combination of everolimus and letrozole in this study for the treatment of endometrial cancer is also investigational. Up to 42 patients will take part in the multicenter study. Up to 42 will be enrolled at MD Anderson.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have signed an approved informed consent.\r\nHistologically confirmed endometrial cancer (endometrioid, serous, or clear cell, or mixed histology; any grade) which is considered progressive or recurrent.\r\nPatients may have failed no more than two prior chemotherapeutic regimens for recurrent or advanced disease (including adjuvant therapy). Chemotherapy administered in conjunction with radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease.\r\nAll patients must have measurable disease as defined by RECIST 1.1.\r\nPatients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions, unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\r\nPatients must have a Zubrod performance status of 0, 1, or 2.\r\nPatients must not be of child bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months. Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < 10 pg/mL to confirm ovarian senescence.\r\nPatients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/Fl, a hemoglobin level of >/=9gm/dL and a platelet count of >100,000/Fl. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.\r\nPatients must have an adequate renal function of >50cc/min as documented by the Cockcroft Gault creatinine clearance formula: Estimated GFR = (140 - age) x (weight kg) divided by 72 x serum Creatinine (non-IDMS) x 0.85 (female)\r\nPatients must have adequate hepatic function as documented by a serum bilirubin </=2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.\r\nAlanine aminotransferase (SGPT) must be </= 3x institutional upper limit of normal unless the liver is involved with tumor, in that case, the alanine aminotransferase must be </= 5 x institutional upper limit of normal.\r\nPrior to beginning therapy, at least 4 weeks must have elapsed since prior chemotherapy, surgery, radiation therapy, hormonal therapy or investigational therapy. Patients receiving palliative radiation therapy are exempt from the 4 week waiting period.\r\nBaseline lipid levels (triglycerides, cholesterol) must be </= grade 1. Patients are allowed to be on lipid lowering drugs.\r\nPatients must be >/= 18 years of age.'}

{'Arm - Disease - Indication': 'Advanced or Recurrent or Progressive Endometrial Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05260671

{'Official Title': 'An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/MSCCHN)', 'Brief Summary': 'This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck', 'Condition': 'Head and Neck Neoplasms\r\nRecurrent Disease\r\nMetastatic Cancer', 'Detailed Description': "Based on the apparent efficacy and favorable safety profile of previous PD-1 and cetuximab combination therapy, Penpulimab (PD-1 antibody) combined with cetuximab in the first-line treatment of patients with recurrent/metastatic SCCHN are used to assess the efficacy and safety of the regimen. Among them, Penpulimab (PD-1 antibody) is approved for adult patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least second-line systemic chemotherapy in China. Cetuximab is approved in China for first-line treatment of recurrent/metastatic SCCHN in combination with chemotherapeutic drugs platinum and fluorouracil.\r\n\r\nThis study plans to enroll 48 patients with untreated recurrent/metastatic squamous cell carcinoma of the head and neck who will receive Penpulimab injection combined with cetuximab. Cetuximab 500 mg/m2 without PD-1 drugs for 14 days prior to Cycle 1. Cetuximab Injection 500 mg/m2 and Penpulimab Injection 200 mg are intravenously infused on Day 1 (D1) of Cycle 1, with 2 weeks (14 days) as a cycle. Penpulimab will be administered for no more than 96 weeks (48 cycles), and cetuximab will be administered until disease progression, unacceptable toxicity, or withdrawal decision by the subject.", 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge: ≥ 18 years, male or female;\r\nHistologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN);\r\nRecurrent/metastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator;\r\nAt least one measurable tumor lesion according to RECIST 1.1 criteria;\r\nThe tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1;\r\nEastern Cooperative Oncology Group (ECOG) PS: 0-1\r\nExpected survival ≥ 3 months;\r\nNormal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 109/L; 3) PLT ≥ 75 × 109/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound;\r\nWomen of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and are willing to use reliable contraception during the trial and must be non-lactating patients; male subjects must use reliable contraception from the start of treatment to 6 months after the last dose;\r\nThe subjects voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up"}

{'Arm - Disease - Indication': 'recurrent/metastatic squamous cell carcinoma of the head and neck'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05385068

{'Official Title': 'An Open-label, Single-arm, Phase II Study to Investigate the Efficacy and Safety of Niraparib Combined With Anlotinib Maintenance Retreatment in PSR Ovarian Cancer Patients, Who Have Previously Received PARPi Maintenance Treatment.', 'Brief Summary': 'This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).', 'Condition': 'Epithelial Ovarian Cancer', 'Detailed Description': "This study will investigate the efficacy and safety of niraparib maintenance re-treatment in patients with PSR non-mucinous EOC, who have previously received maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy). Patients will be enrolled, given niraparib and anlotinib maintenance treatment until disease progression or untolerated toxicity.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nProvision of informed consent prior to any study specific procedures.\nFemale patients ≥18 years of age, with histologically diagnosed platinum sensitive recurrent high-grade serous or endometrioid epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer).\nBRCA mutation status is known.\nPatients must have received one prior PARPi therapy, PARPi therapy includes any agent (including niraparib) used in a maintenance setting and the duration of maintenance treatment ≥6 months.\nPatients had received ≤3 lines of chemotherapy, the time between the penultimate line of platinum-containing chemotherapy and the last platinum-containing chemotherapy was > 6 months. For example, if a patient receives a non-platinum type of chemotherapy between the penultimate line of platinum-containing chemotherapy and the last platinum-containing chemotherapy, patient will be eligible if all the eligibility criteria are met.\nThe most recent round of platinum-containing chemotherapy should have included ≥4 cycles of treatment , in the opinion of the investigator, in response (partial or complete radiological response) or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy) .\nPatients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during last line chemotherapy and that is stable for at least 7 days (ie, no increase > 15% from nadir).\nPatients can have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of therapy is permitted.\nPatients must be enrolled within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion).\nPatients must have a life expectancy ≥4 months.\nEastern Cooperative Oncology Group performance status 0-2.\nPatients must have normal organ and bone marrow function, defined as follows: Absolute neutrophil count ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 10 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation; Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN; Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\nNegative serum or urine pregnancy test prior to receiving the first dose of study treatment and willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 90 days after the last dose of study treatment; or women of with no potential fertility.\nAbility to comply with protocol.\nAll of the adverse events caused by chemotherapy recovered to Common Terminology Criteria Adverse Events (CTCAE) grade 1 or baseline, except for stable sensory neuropathy or hair loss ≤ CTCAE grade 2.'}

{'Arm - Disease - Indication': 'Previously Treated Platinum-Sensitive Recurrent Ovarian Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04224493

{'Official Title': 'Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma\n', 'Brief Summary': "The participants of this study would have relapsed/refractory follicular lymphoma.\r\n\r\nFollicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works.\r\n\r\nStage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.\r\n\r\nStage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combinatio", 'Condition': 'Relapsed/Refractory Follicular Lymphoma', 'Detailed Description': 'Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.\r\nMales or females are ≥18 years of age (≥20 years for Taiwan) at the time of providing voluntary written informed consent.\r\nLife expectancy ≥3 months before enrollment.\r\nSubjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 but with normal ALT and are hepatitis B surface antigen negative with undetectable HBV DNA and/or have undetectable hepatitis C virus (HCV) RNA if HCV antibody positive.\r\nHave histologically confirmed FL, Grades 1 to 3A.\r\nMust have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:\r\n\r\na. Systemic therapy includes treatments such as:\r\n\r\ni. Rituximab monotherapy\r\n\r\nii. Chemotherapy given with or without rituximab\r\n\r\niii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.\r\n\r\nb. Systemic therapy does not include, for example:\r\n\r\ni. Local involved field radiotherapy for limited-stage disease\r\n\r\nii. Helicobacter pylori eradication\r\n\r\nc. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.\r\n\r\nd. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.\r\n\r\ne. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.\r\n\r\nMust have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).\r\nHave measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\r\nFor subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy):\r\n\r\na. At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.\r\n\r\nHave provided sufficient tumor tissue for EZH2 mutation testing in all subjects to allow for stratification and for CNG determination in a subset of WT EZH2 subjects from the Phase 3 portion of the study.\r\n\r\na. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.\r\n\r\nNOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.\r\n\r\nTime between prior anticancer therapy and first dose of tazemetostat as follows:\r\n\r\nCytotoxic chemotherapy - At least 21 days.\r\nNoncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.\r\nNitrosoureas - At least 6 weeks.\r\nMonoclonal and/or bispecific antibodies or CAR T - At least 28 days.\r\nRadiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.\r\nAdequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.\r\nAdequate bone marrow function:\r\n\r\na. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration\r\n\r\nWithout growth factor support (filgrastim or pegfilgrastim) for at least 14 days.\r\n\r\nb. Platelets ≥75,000/mm3 (≥75 × 10^9/L)\r\n\r\nEvaluated at least 7 days after last platelet transfusion.\r\n\r\nc. Hemoglobin ≥9.0 g/dL\r\n\r\nMay receive transfusion\r\nAdequate liver function:\r\n\r\nTotal bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.\r\nAlkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).\r\nInternational normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.\r\nFemales of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).\r\nFemales of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:\r\n\r\nExamples of highly effective methods:\r\n\r\nIntrauterine device (IUD)\r\nHormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.\r\nBilateral tubal ligation\r\nPartner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).\r\nExamples of additional effective methods:\r\n\r\nMale latex or synthetic condom,\r\nDiaphragm,\r\nCervical Cap\r\nNOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n\r\nAll study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used.\r\n\r\na. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.\r\n\r\nMale subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\r\nNOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation."}

{'Arm - Disease - Indication': 'Previously Treated Relapsed/\u200bRefractory Follicular Lymphoma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04224493

{'Official Title': 'Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma\r', 'Brief Summary': "The participants of this study would have relapsed/refractory follicular lymphoma.\r\n\r\nFollicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works.\r\n\r\nStage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.\r\n\r\nStage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combinatio", 'Condition': 'Relapsed/Refractory Follicular Lymphoma', 'Detailed Description': 'Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.\r\nMales or females are ≥18 years of age (≥20 years for Taiwan) at the time of providing voluntary written informed consent.\r\nLife expectancy ≥3 months before enrollment.\r\nSubjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 but with normal ALT and are hepatitis B surface antigen negative with undetectable HBV DNA and/or have undetectable hepatitis C virus (HCV) RNA if HCV antibody positive.\r\nHave histologically confirmed FL, Grades 1 to 3A.\r\nMust have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:\r\n\r\na. Systemic therapy includes treatments such as:\r\n\r\ni. Rituximab monotherapy\r\n\r\nii. Chemotherapy given with or without rituximab\r\n\r\niii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.\r\n\r\nb. Systemic therapy does not include, for example:\r\n\r\ni. Local involved field radiotherapy for limited-stage disease\r\n\r\nii. Helicobacter pylori eradication\r\n\r\nc. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.\r\n\r\nd. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.\r\n\r\ne. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.\r\n\r\nMust have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).\r\nHave measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\r\nFor subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy):\r\n\r\na. At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.\r\n\r\nHave provided sufficient tumor tissue for EZH2 mutation testing in all subjects to allow for stratification and for CNG determination in a subset of WT EZH2 subjects from the Phase 3 portion of the study.\r\n\r\na. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.\r\n\r\nNOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.\r\n\r\nTime between prior anticancer therapy and first dose of tazemetostat as follows:\r\n\r\nCytotoxic chemotherapy - At least 21 days.\r\nNoncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.\r\nNitrosoureas - At least 6 weeks.\r\nMonoclonal and/or bispecific antibodies or CAR T - At least 28 days.\r\nRadiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.\r\nAdequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.\r\nAdequate bone marrow function:\r\n\r\na. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration\r\n\r\nWithout growth factor support (filgrastim or pegfilgrastim) for at least 14 days.\r\n\r\nb. Platelets ≥75,000/mm3 (≥75 × 10^9/L)\r\n\r\nEvaluated at least 7 days after last platelet transfusion.\r\n\r\nc. Hemoglobin ≥9.0 g/dL\r\n\r\nMay receive transfusion\r\nAdequate liver function:\r\n\r\nTotal bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.\r\nAlkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).\r\nInternational normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.\r\nFemales of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).\r\nFemales of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:\r\n\r\nExamples of highly effective methods:\r\n\r\nIntrauterine device (IUD)\r\nHormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.\r\nBilateral tubal ligation\r\nPartner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).\r\nExamples of additional effective methods:\r\n\r\nMale latex or synthetic condom,\r\nDiaphragm,\r\nCervical Cap\r\nNOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n\r\nAll study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used.\r\n\r\na. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.\r\n\r\nMale subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\r\nNOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation."}

{'Arm - Disease - Indication': 'Previously Treated Relapsed/\u200bRefractory Follicular Lymphoma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03400332

{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}

{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03400332

{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}

{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03400332

{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}

{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03400332

{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}

{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03400332

{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}

{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03924869

{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor"}

{'Arm - Disease - Indication': 'Adult Previously Untreated Unresected Stage I or Stage II Non-Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03924869

{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor"}

{'Arm - Disease - Indication': 'Adult Previously Untreated Unresected Stage I or Stage II Non-Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02667587

{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nMales and Females, age ≥ 18 years old\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\nKarnofsky performance status of ≥ 70 (able to take care of self)\nSubstantial recovery from surgery resection\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}

{'Arm - Disease - Indication': 'Newly Diagnosed Adult MGMT-Methylated Glioblastoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02667587

{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMales and Females, age ≥ 18 years old\r\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\r\nKarnofsky performance status of ≥ 70 (able to take care of self)\r\nSubstantial recovery from surgery resection\r\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}

{'Arm - Disease - Indication': 'Newly Diagnosed Adult MGMT-Methylated Glioblastoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02446704

{'Official Title': 'Phase I/II Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy', 'Brief Summary': 'This research study is evaluating the combination of olaparib and temozolomide as a possible treatment for Small Cell Lung Cancer.', 'Condition': 'Small Cell Lung Cancer', 'Detailed Description': 'This research study is a Phase I/II clinical trial, which has two parts. The participant will be asked to participate in one part of the study. The first part tests the safety of the combination of drugs and tries to define the appropriate dose to use for future studies. The second part tests whether the combination of drugs is effective in treating small cell lung cancer. "Investigational" means that the combination of drugs is being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved the combination of drugs for Small Cell Lung Cancer.\r\n\r\nOlaparib (Lynparza) is FDA approved for the treatment of a type of ovarian cancer associated with a particular DNA change. Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with small cell lung cancer. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for other cancer.\r\n\r\nTemozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in small cell lung cancer in previous research studies. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for relapsed disease.\r\n\r\nIn this research study, the investigators are looking for the maximum tolerated dose or MTD of the combination of olaparib and temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on small cell lung cancer', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must meet the following criteria on screening examination to be eligible to participate in the study. The eligibility criteria apply to both the phase I and phase II portions of the study.\r\nParticipant must have histologically or cytologically confirmed small cell lung cancer and may not be a candidate for potentially curative therapy.\r\nPresence of measurable disease (RECIST 1.1): At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.\r\nThe small cell lung cancer must have progressed radiographically following a platinum-based (cisplatin and/or carboplatin) standard prior chemotherapy regimen. Any number of interval prior lines of therapy is allowed. Patients who have received prior platinum-based chemotherapy and radiation for limited stage SCLC and have subsequently developed relapsed disease are eligible, as long as the platinum-based therapy was given within 12 months prior to the time of relapse.\r\nParticipant (male/female) must be ≥18 years of age.\r\nParticipant must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\r\n\r\nHemoglobin ≥ 10.0 g/dL\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\r\nPlatelet count ≥100 x 10^9/L\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\r\nAST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (unless liver metastases are present in which case it must be ≤5 x ULN)\r\nSerum creatinine ≤1.5 x institutional upper limit of normal (ULN)\r\nECOG performance status 0-1\r\nParticipant must have a life expectancy ≥ 16 weeks.\r\nWomen of childbearing potential must have a negative urine or serum pregnancy test within 28 days of initial dose of olaparib and temozolomide AND must agree to the use of two highly effective forms of contraception (see Section 5.5) throughout their participation in the study and for at least 3 months after the last dose of olaparib and temozolomide, OR confirmed prior to treatment on day 1 to be postmenopausal or surgically sterile. Postmenopausal is defined as:\r\n\r\nAmenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\nLH and FSH levels in the post menopausal range for women under 50,\r\nradiation-induced oophorectomy with last menses >1 year ago,\r\nchemotherapy-induced menopause with >1 year interval since last menses, or surgical sterilisation (bilateral oophorectomy or hysterectomy).\r\nParticipant is willing to comply with the protocol for the duration of the study, and undergo treatment and scheduled visits and examinations including follow up. Participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide.'}

{'Arm - Disease - Indication': 'Recurrent Previously Treated Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05561036

{'Official Title': 'A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor', 'Brief Summary': 'The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period', 'Condition': 'Desmoid Tumor', 'Detailed Description': 'A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMust be confirmed as desmoid tumor by histopathology\r\nPatients should have measurable lesions defined by RECIST v1.1\r\nOne of the following conditions is satisfied\r\n\r\nThe disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics\r\n\r\nMultiple lesions\r\n\r\nThe disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary\r\n\r\nLarge tumor or multiple chambers involved\r\nImaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)\r\nThe BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:\r\n\r\nNSAIDs can not control pain, and consider increasing the control of narcotic drugs\r\n\r\nCurrent use of narcotic drugs increased by 30%\r\n\r\nNew opioid anesthetics needed\r\nPatients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2\r\nAge ≥ 1 year old, male or female\r\nECoG score ≤ 2\r\nResults of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein < 2+\r\nFemale subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)\r\nUnderstand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits'}

{'Arm - Disease - Indication': 'Desmoid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05561036

{'Official Title': 'A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor', 'Brief Summary': 'The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period', 'Condition': 'Desmoid Tumor', 'Detailed Description': 'A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMust be confirmed as desmoid tumor by histopathology\r\nPatients should have measurable lesions defined by RECIST v1.1\r\nOne of the following conditions is satisfied\r\n\r\nThe disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics\r\n\r\nMultiple lesions\r\n\r\nThe disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary\r\n\r\nLarge tumor or multiple chambers involved\r\nImaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)\r\nThe BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:\r\n\r\nNSAIDs can not control pain, and consider increasing the control of narcotic drugs\r\n\r\nCurrent use of narcotic drugs increased by 30%\r\n\r\nNew opioid anesthetics needed\r\nPatients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2\r\nAge ≥ 1 year old, male or female\r\nECoG score ≤ 2\r\nResults of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein < 2+\r\nFemale subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)\r\nUnderstand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits'}

{'Arm - Disease - Indication': 'Desmoid Tumor'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04982237

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04982237

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03631199

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\r\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\r\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\r\nAt least 1 measurable lesion by RECIST 1.1'}

{'Arm - Disease - Indication': 'Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03631199

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\n\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\nAt least 1 measurable lesion by RECIST 1.1'}

{'Arm - Disease - Indication': 'Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05052801

{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment"}

{'Arm - Disease - Indication': 'Previously Untreated FGFR2b Overexpressed Adult Unresectable Advanced Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}