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A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

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Trial Profile

A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

  • Drugs Gemcitabine (Primary) ; Mitomycin
  • Indications Bladder cancer
  • Focus Therapeutic Use
  • Acronyms SunRISe-5
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 23 Apr 2024 Status changed from not yet recruiting to recruiting.
  • 30 Jan 2024 Planned End Date changed from 14 Mar 2031 to 14 Apr 2031.
  • 23 Jan 2024 New trial record

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