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A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

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A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

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

Latest Information Update: 13 Oct 2024

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Pembrolizumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-B15; KEYNOTE-B15 / EV-304
  • 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 Nov 2023 Status changed from recruiting to active, no longer recruiting.
    • 18 Feb 2023 Trial design presented at the 2023 Genitourinary Cancers Symposium

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