OncRef

Clinical Trial: NCT04225117

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Astellas Pharma Global Development, Inc.
Information Provided By:Astellas Pharma Inc
Last Update Posted:2026-09-23

Study Overview

Brief 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.

Official Title

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Conditions

Locally Advanced or Metastatic Malignant Solid Tumors

Intervention / Treatment

  • Drug: enfortumab vedotin
  • Drug: pembrolizumab

Other Study ID Numbers

  • 7465-CL-202
  • KEYNOTE-F21
  • MK-3475-F21
  • jRCT2080225095

Start Date (Actual)

2020-03-10

Primary Completion Date (Actual)

2025-02-25

Study Completion Date (Estimated)

2027-03-31

Enrollment (Actual)

329

Study Type

Interventional

Phase

Phase 2