NCT03219333 (Clinical Trial | Enfortumab Vedotin | EV-201)

Trial Description

This trial (NCT03219333)  is a first patient trial in EV-201, a registrational phase II clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

This trial is sponsored by Astellas Pharma ( Astellas Pharma Global Development) and Seattle Genetics.

Study Data

  • Condition: locally advanced or metastatic urothelial cancer
    • Carcinoma, Transitional Cell
    • Urinary Bladder Neoplasms
    • Urologic Neoplasms
    • Renal Pelvis Neoplasms
    • Urothelial Cancer
    • Ureteral Neoplasms
    • Urethral Neoplasms
  • Interventions:
    • Drugs used in this trial
      • enfortumab vedotin
  • Phase: II
  • Enrollment: ~120
  • Start: Late 2017
  • Estimated Completion: Not yet known
  • Last verified: October 2017

Study Schematic

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Last Editorial review: October 2017
Information based on (NIH/NCI) and other sources.