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A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D

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Trial Profile

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Feb 2026

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At a glance

  • Drugs SKB-410 (Primary) ; Enfortumab vedotin; Pembrolizumab
  • Indications Carcinoma; Urogenital cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms KEYMAKER-U04
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 06 Feb 2026 Planned initiation date changed from 30 Jan 2026 to 27 Feb 2026.
  • 20 Jan 2026 Planned initiation date changed from 9 Jan 2026 to 30 Jan 2026.
  • 07 Jan 2026 Planned initiation date changed from 31 Dec 2025 to 9 Jan 2026.

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