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A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

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A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs Enfortumab vedotin (Primary)
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Squamous cell cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EV-201
  • Sponsors Astellas Pharma; Seagen

    • Most Recent Events

    • 27 Sep 2023 Status changed from active, no longer recruiting to completed.
    • 09 Mar 2023 According to an Astellas Pharma Inc. media release, results from cohort 1 of this and EV-301 clinical trials serve as core data to support the Marketing Authorization Applications for enfortumab vedotin in the global market, including the European Union, Japan and Singapore.
    • 09 Mar 2023 According to an Astellas Pharma Inc. media release, results of cohort 2 of this and EV-301 clinical trials supported the full and supplemental approval of PADCEV (enfortumab vedotin-ejfv) by the U.S. Food and Drug Administration in July 2021.

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