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A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

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A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Oct 2024

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At a glance

  • Drugs Cetrelimab (Primary) ; Gemcitabine (Primary)
  • Indications Bladder cancer; Carcinoma; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms SunRISe-4
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 08 Oct 2024 Planned End Date changed from 16 Mar 2027 to 7 Mar 2027.
    • 08 Oct 2024 Planned primary completion date changed from 1 Dec 2026 to 19 Feb 2025.
    • 16 Sep 2024 According to a Janssen Media Release, interim data from this study were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress.

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