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A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

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Trial Profile

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

  • Drugs Cetrelimab (Primary) ; Gemcitabine (Primary) ; Gemcitabine (Primary) ; BCG vaccine
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms SUNRISE-3
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 29 Oct 2024 Status changed from recruiting to active, no longer recruiting.
  • 23 Apr 2024 Planned End Date changed from 18 Sep 2030 to 18 Sep 2029.
  • 27 Mar 2024 Planned End Date changed from 9 May 2030 to 18 Sep 2030.

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