Overview and results of all trials<unk>  clinical trials (as of September 2, 2014) sorted by (estimated) primary completion date: Clinical trials: Lung cancer, Breast cancer, Prostate cancer, Colorectal cancer, and Multiple myeloma NCT Number /Title Other IDs Start Date (Estimated) Primary Completion Date Recruitment Conditions Interventions Phases Enrollment (Patients) Sponsor / Collaborators B25-LG-304 / EMR 63325-005 August 2000 March 2006 Lung Neoplasms, Carcinoma, Non-Small-Cell Lung Biological: BLP25 Liposome Vaccine plus best supportive care; Other: Best Supportive Care (BSC) Phase 2 171 Merck KGaA ' A Phase IIb clinical trial of 171 patients with inoperable stage IIIb non-small-cell lung cancer (NSCLC), in which<unk>  showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving<unk>  plus BSC. Although this represents a subgroup analysis that is not statistically significant (with a nonsignificant P-value: p = 0.16), the magnitude of the difference and its durability over a prolonged period of follow up suggest an efficacy signal for the vaccine and would support further testing of<unk>  in a definitive phase III trial. Reported side effects included mild-to-moderate flu-like symptoms, gastrointestinal disturbances, and mild injection-site reactions. NCT00157196 Safety Study of BLP25 Liposome Vaccine in Non-Small Cell Lung Cancer Patients With Unresectable Stage III Disease B25-LG-305 / EMR 63325-006 April 2005 September 2009 Carcinoma, Non-Small-Cell Lung, Lung Neoplasms Biological: BLP25 Liposome Vaccine Phase 2 22 Merck KGaA NCT00925548 STRIDE - STimulating Immune Response In aDvanced brEast Cancer ', EMR 200038–010, 2008-005544-17 September 2009 August 2010 Breast Cancer Biological:<unk>  (L-BLP25) and Hormonal Treatment, Biological: Placebo of<unk>  (L-BLP25) and Hormonal Treatment, Drug: cyclophosphamide, Drug: sodium chloride (NaCl) Phase 3 16 EMD Serono A thirty-site phase III trial (STRIDE) began in September 2009 on 900 women. The purpose of this study is to determine whether the addition of<unk>  to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent, or metastatic breast cancer. ' The U.S. Food and Drug Administration (FDA) put the Phase III STRIDE trial on hold in March 2010 after a patient participating in a Phase II clinical trial with<unk>  in patients with multiple myeloma developed encephalitis. The study was terminated in August 2010 (16 patients were enrolled in the study). NCT01094548 Study of Stimuvax in Patients With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy EMR63325-008 February 2008 February 2011 Multiple Myeloma Biological: L-BLP25, cyclophosphamide prior to first vaccination, Biological: L-BLP25 Phase 2 34 Merck KGaA NCT00409188 Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer ', EMR 63325-001 January 2007 August 2012 Non-small Cell Lung Cancer Biological:<unk>  (L-BLP25), Biological: Placebo Phase 3 1513 EMD Serono, Merck KGaA ' The primary endpoint of overall survival was not met in the START trial. However, the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study. NCT01731587 Anti-cancDer MUC1-specific Immunotherapy for Unresectable Stage III Non-small Cell Lung Cancer ', EMR 63325–019, 2012-001435-31 Non-small Cell Lung Cancer (NSCLC) Stage III Other: Biological: MUC1 peptide specific immunotherapy, Drug: Cyclophosphamide (CPA) Phase 1 0 Merck KGaA NCT00960115 Study of EMD531444 in Subjects With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy EMR063325-009 December 2008 May 2014 Non-small Cell Lung Cancer Biological: cyclophosphamide + EMD531444 + BSC, Biological: Saline + Placebo + BSC Phase 1, Phase 2 205 Merck KGaA, Merck Serono Co., Ltd., Japan ' The analysis of EMR 63325–009, a randomized, double-blind, placebo-controlled, Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy shows the following results: Of the patients included in the Phase II part of the study, the majority had received concurrent CRT. The results indicate that no effect has been observed for either the primary endpoint, overall survival (OS), or any of the secondary endpoints (progression-free survival PFS, time to progression TTP, and time to treatment failure). An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups. Merck Serono made the recommendation to stop the investigational treatment for patients in the EMR 63325-009 study in Japan. EudraCT: 2011-004822-85 A prospective, open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax) in the pre-operative treatment of women with primary breast cancer ABCSG-34 / EMR 63325-603 Jan 2012 May 2014 Breast Cancer L-BLP25 (Stimuvax), Cyclophosphamide (CPA), LETROZOLE, EPIRUBICIN, DOCETAXEL Phase 2 400 ABCSG (Austrian Breast & Colorectal Cancer Study Group) ' 8 May 2012 *Enrollment expected to be completed in May 2014 *First results available end of 2014 26 Sept 2014 *Enrollment of 400 patients completed NCT01507103<unk>  (L-BLP25) in Rectal Cancer ', EMR063325-013, 2011-000847-25 February 2012 June 2014 Rectal Cancer Cyclophosphamide (CPA),<unk>  (L-BLP25) Phase 2 124 Merck KGaA NCT00828009 BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery CDR0000632611, E6508 December 2010 January 2016 Lung Cancer Biological: bevacizumab, Biological: emepepimut-S, Drug: carboplatin, Drug: cyclophosphamide, Drug: paclitaxel, Radiation: radiation therapy Phase 2 55 Eastern Cooperative Oncology Group, National Cancer Institute (NCI) NCT01462513 L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases LICC01 August 2011 September 2016 Colon Carcinoma, Rectum Carcinoma Biological: L-BLP25, Biological: Placebo Phase 2 159 Johannes Gutenberg University Mainz, Dr. Carl Schimanski NCT01496131<unk>  (L-BLP25) in Prostate Cancer EMR 63325–015, BB-IND 7787 October 2011 August 2017 Prostate Cancer Radiation: Radiation therapy, Drug: Goserelin, Drug: Cyclophosphamide, Drug:<unk>  (L-BLP25) Phase 2 48 EMD Serono, National Cancer Institute (NCI) NCT02049151<unk>  Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer ', EMR 63325–021, 2013-003760-30 March 2014 July 2018 Carcinoma, Non-Small-Cell Lung Drug:<unk> , Drug: Placebo, Drug: Cyclophosphamide (CPA), Drug: Saline (sodium chloride) Phase 3 1002 EMD Serono NCT01423760 Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials EMR 63325-011 January 2012 December 2019 Non-Small Cell Lung Cancer, Multiple Myeloma Biological:<unk> , Other: No intervention 262 Merck KGaA NCT01015443 Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population ', EMR63325-012 December 2009 May 2020 Non-Small Cell Lung Cancer Biological:<unk>  (L-BLP25), Biological: Placebo Phase 3 500 Merck KGaA Note: Merck KGaA and Oncothyreon are not reporting in their annual reports on colorectal cancer trials and prostate cancer trials Overview of completed trials Overview of completed<unk>  trials (as of September 2, 2014) where results have been published, sorted by primary completion date: ID Phase Indication Start Primary Completion Date Summary of the results EMR 63325-005 2 NSCLC August 2000 March 2006 Subgroup analysis favorable. START, EMR 63325-001 3 NSCLC January 2007 August 2012 Primary endpoint not met. Subgroup analysis favorable. EMR 63325-009 (Japan study) 1, 2 NSCLC December 2008 May 2014 Primary endpoint and secondary endpoints not met. Subgroup analysis not favorable. Discontinued development On August 18 and September 12, 2014, Oncothyreon and Merck KGaA, respectively, reported that a randomized Phase 1/2 study, EMR 63325–009, of<unk>  compared to a placebo in Japanese patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression-free survival, time to progression, or time to failure). Merck made the recommendation to stop the investigational treatment of patients in the EMR 63325-009 study in Japan. Furthermore, Merck KGaA announced its decision to discontinue the Phase III START2 and INSPIRE studies, and all other Merck-sponsored clinical trials with<unk>  in NSCLC, worldwide. Merck will continue to supply<unk>  for ongoing investigator-sponsored trials in other indications in accordance with their agreements with the sponsors of these studies.
Tecemotide
Pasireotide
Nangibotide
Crofelemer
Damoctocog alfa pegol
Efgartigimod alfa
Etelcalcetide
Desmopressin