Clinical trial

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With…

NCT03474107 · Astellas Pharma Global Development, Inc., Industry · Completed

Key facts

NCT number NCT03474107
Title A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Official title 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)
Lead sponsor Astellas Pharma Global Development, Inc., Industry
Collaborators Seagen Inc. Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Ureteral Cancer, Urothelial Cancer, Bladder Cancer
Intervention type Drug
Interventions Enfortumab Vedotin, Docetaxel, Vinflunine, Paclitaxel
Enrollment 608
Start date Jun 27, 2018
Primary completion Jul 15, 2020
Completion Nov 27, 2025
First posted Mar 22, 2018
Last update posted Jan 9, 2026
Countries Argentina, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Portugal and 7 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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