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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: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 03 Aug 2026

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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

  • 24 Mar 2026 Status changed from active, no longer recruiting to discontinued. The study was stopped by the sponsor after meeting enrollment targets and primary objectives, and after collecting sufficient data for planned regulatory filings, and not due to safety concerns/futility or any regulatory request.
  • 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).

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