A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

本项II期单臂临床试验旨在评估阿替利珠单抗（atezolizumab）治疗局部晚期或转移性尿路上皮膀胱癌患者的疗效。受试者将被纳入两个队列之一。队列1（即本报告所载队列）将纳入初治且无法耐受含顺铂化疗的患者；队列2将纳入既往接受铂类化疗期间或之后出现疾病进展的患者。队列2的研究结果已在另一项临床试验（NCT02108652）中单独报告。两个队列的受试者均每21天为一个治疗周期，于周期第1天接受1200毫克（mg）静脉（intravenous, IV）输注的阿替利珠单抗。队列1受试者的治疗将持续至按照实体瘤疗效评价标准1.1版（RECIST v1.1）评估出现疾病进展，或出现不可耐受的毒性反应。队列2受试者的治疗将持续至临床获益丧失，或出现不可耐受的毒性反应。