CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 329 enrolled / 329 target
Drug / intervention
enfortumab vedotin +1 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/NCT04225117
NCT04225117Phase 2ActiveUpdate Overdue (4.3/mo)Completion was 16mo ago
CompareCT.gov

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

Astellas Pharma Global Development, Inc.·interventional·Posted Jan 13, 2020·Updated Jun 16, 2026

In Brief

A Phase 2 clinical trial evaluating enfortumab vedotin and pembrolizumab for Locally Advanced or Metastatic Malignant Solid Tumors. Active but no longer recruiting, targeting 329 participants across 39 sites in 3 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic Malignant Solid Tumors
CountriesCanada, Japan, United States
CollaboratorsSeagen Inc., Merck Sharp & Dohme LLC

Timeline

Phase 2Active
2020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartMar 10, 2020
Primary CompletionFeb 25, 2025
Study CompletionSep 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 6.5 years ago

Arms & Interventions

Cohort 1: HR+/HER2- breast cancerexperimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. HR+/HER2- = Hormone receptor-positive/ human epidermal growth factor receptor 2-negative

Drug: enfortumab vedotin
Cohort 2: Triple negative breast cancer (TNBC)experimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 3: Squamous non-small cell lung cancerexperimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 4: Non-squamous non-small cell lung cancerexperimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 5: Head and neck cancerexperimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 6: Gastric or GEJ or esophageal cancerexperimental

Participants enrolled into Cohort 6 will be reallocated based on disease type and histology into Cohorts 7 or 8. GEJ= gastroesophageal junction

Drug: enfortumab vedotin
Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinomaexperimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 8: Esophageal squamous cell carcinoma (ESCC)experimental

Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.

Drug: enfortumab vedotin
Cohort 9: Head and neck squamous cell carcinoma (HNSCC)experimental

Participants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.

Drug: enfortumab vedotinDrug: pembrolizumab

Interventions

enfortumab vedotindrug

intravenous (IV) infusion

pembrolizumabdrug

IV infusion