Clinical Trial

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Active, Not Recruiting Phase 2
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Summary
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.
Protocol Amendment History 68 amendments
This ClinicalTrials.gov record has been amended 68 times since 2020-01-09; most recent amendment 2026-06-12.
Status change: Recruiting → Active, Not Recruiting 2024-09-09
Status change: Active, Not Recruiting → Recruiting 2023-10-31
Status change: Recruiting → Active, Not Recruiting 2022-11-24
Status change: Active, Not Recruiting → Recruiting 2020-06-02
Status change: Recruiting → Active, Not Recruiting 2020-05-05
Status change: Not Yet Recruiting → Recruiting 2020-03-12
Trial Details
NCT Number NCT04225117
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Seagen Inc., Merck Sharp & Dohme LLC
Conditions Locally Advanced or Metastatic Malignant Solid Tumors
Enrollment 329 participants
Start Date 2020-03-10
Primary Completion 2025-02-25 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-16