What is the role of nivolumab in the treatment of metastatic bladder cancer?

Updated: Feb 23, 2021
  • Author: Kara N Babaian, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
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Answer

Nivolumab also gained accelerated approval for advanced or metastatic urothelial carcinoma from the FDA. Approval was based on the CheckMate-275, single-arm, phase II clinical trial (n=270). ORR, confirmed by an independent radiographic review committee using Response Evaluation Criteria in Solid Tumors 1.1, was 19.6% (52/265; 95% confidence index [CI]: 15.0-24.9). Seven patients had complete responses and 46 had partial responses. Estimated median response duration was 10.3 months, with responses ongoing at data cutoff. [137]


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