- e. Expansion Cohort 3: Subjects with UC (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced, or metastatic disease [Ineligible for cisplatin-based chemotherapy is defined by meeting one of the following criteria: impaired renal function (glomerular filtration rate [GFR] > 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2), hearing loss of ≥ 25 dB at two contiguous frequencies, or ≥ Grade 2 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v4.]