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)
Latest Information Update: 30 Dec 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.
- 24 Dec 2024 Planned number of patients changed from 784 to 808.
- 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.