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An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

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Trial Profile

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Enfortumab vedotin (Primary) ; Docetaxel; Paclitaxel; Vinflunine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Squamous cell cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EV-301
  • Sponsors Astellas Pharma Global Development
  • Most Recent Events

    • 19 Sep 2024 Planned End Date changed from 31 Aug 2024 to 28 Feb 2025.
    • 19 Aug 2024 According to an Astellas Pharma media release, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
    • 01 Jun 2024 Results assessing patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life published in the European Urology

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