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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: 15 Oct 2025

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Sarcoma; 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

  • 01 Oct 2025 According to a Astellas Pharma media release, Long-term follow-up data from the EV-302 clinical trial will be featured in an ESMO Presidential Symposium exploring the utility of enfortumab vedotin in combination with pembrolizumab for patients with challenging baseline characteristics, including older patients with locally advanced or metastatic urothelial cancer and those with comorbidities such as diabetes and chronic kidney disease.
  • 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).

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