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A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

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Trial Profile

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

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

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Linrodostat (Primary) ; Nivolumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb; Ono Pharmaceutical

Most Recent Events

  • 31 May 2025 Timeframe for primary endpoint 'Event-Free Survival' has been changed from 51 months to 36 months.
  • 31 May 2025 Planned primary completion date changed from 4 Apr 2025 to 17 Nov 2025.
  • 07 Sep 2024 The trial has been completed in Portugal, European Clinical Trials Database record.

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