A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

Active:	No
Cancer Type:	Ureter Cancer Urethral Cancer	NCT ID:	NCT02108652
Trial Phases:	Phase II	Protocol IDs:	GO29293 (primary)
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT02108652

Summary

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 will consist of participants who are
treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1
are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who
have progressed during or following a prior platinum-based chemotherapy regimen. 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.

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