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A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

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Trial Profile

A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

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

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Sasanlimab (Primary) ; BCG
  • Indications Bladder cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CREST
  • Sponsors Pfizer

Most Recent Events

  • 26 Apr 2025 According to Pfizer media release, results from this trial presented at the 2025 American Urological Association (AUA) Annual Meeting.
  • 26 Apr 2025 According to Pfizer media release, results from this trial have been shared with global health authorities to support potential regulatory filings
  • 26 Apr 2025 Results presented in the Pfizer Media Release

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