CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 608 enrolled
Drug / intervention
Enfortumab Vedotin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03474107
NCT03474107Phase 3Completed
CompareCT.gov

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)

Astellas Pharma Global Development, Inc.·interventional·Posted Mar 22, 2018·Updated Jan 9, 2026

In Brief

A Phase 3 clinical trial evaluating Enfortumab Vedotin, Docetaxel, and 2 other interventions for Ureteral Cancer and 2 related conditions. Completed, enrolled 608 participants across 158 sites in 19 countries.

Detailed Summary

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUreteral Cancer, Urothelial Cancer, Bladder Cancer
CountriesArgentina, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsSeagen Inc.

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 22, 2018
Enrollment StartJun 27, 2018
Primary CompletionJul 15, 2020
Study CompletionNov 27, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.3 years ago

Interventions

Enfortumab Vedotindrug

Intravenous infusion

Docetaxeldrug

Intravenous infusion

Vinfluninedrug

Intravenous infusion

Paclitaxeldrug

Intravenous infusion