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A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

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Trial Profile

A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Nov 2025

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Squamous cell cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EV-103; KEYNOTE-869
  • Sponsors Astellas Pharma Global Development; Seagen

Most Recent Events

  • 01 Oct 2025 According to an Astellas Pharma media release, data from this trial EV-103 Cohort K: Efficacy and safety of enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer with a median follow-up of approx. 3.5 y, will be featured in an ESMO Presidential Symposium.
  • 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).
  • 02 May 2025 Planned End Date changed from 31 Dec 2026 to 11 Sep 2026.

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