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A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

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Trial Profile

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

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

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ENCORE; KEYNOTE905; MK-3475-905/KEYNOTE-905/EV-303
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 26 Jul 2024 According to a Merck and Co media release, Merck, in collaboration with Pfizer and Astellas, are evaluating KEYTRUDA plus enfortumab vedotin combination as part of an extensive clinical development program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in muscle-invasive bladder cancer in KEYNOTE-B15 (also known as EV-304) and KEYNOTE-905 (also known as EV-303).
  • 17 May 2024 Status changed from recruiting to active, no longer recruiting.
  • 06 Jun 2023 Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology.

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