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An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

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Trial Profile

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2025

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At a glance

  • Drugs Disitamab vedotin (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DV-001
  • Sponsors Pfizer; Seagen

    • Most Recent Events

    • 04 Feb 2025 Planned number of patients changed from 700 to 400.
    • 04 Jun 2024 Study design were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
    • 27 Jan 2024 According to Trial design presented at the 2024 Genitourinary Cancers Symposium, enrollment is currently ongoing in the United States and planned globally.

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