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An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

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Trial Profile

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

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

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Squamous cell cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EV-302; KEYNOTE-A39
  • Sponsors Astellas Pharma Global Development; Seagen

Most Recent Events

  • 13 Jun 2025 Planned End Date changed from 30 Nov 2027 to 1 Mar 2028.
  • 19 May 2025 According to a Astellas Pharma media release, data from this trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3).
  • 23 Apr 2025 According to an pfizer media release, new exploratory analyses will be presented 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3 in Chicago.

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