A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Phase 2
Active, not recruiting
NCT04225117
| Condition | Locally Advanced or Metastatic Malignant Solid Tumors |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | Astellas Pharma Global Development, Inc. |
|---|
| Status | Active, not recruiting |
|---|
| Enrollment | 329 participants |
|---|
| Interventions | enfortumab vedotin, pembrolizumab |
|---|
| Start date | Mar 10, 2020 |
|---|
| Completion date | Feb 25, 2025 |
|---|
| Results posted | Apr 13, 2026 |
|---|
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.
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment
Up to 20.04 months · Percentage of participants
| Cohort 1: HR+/HER2- Breast Cancer | 15.6 Percentage of participants |
|---|
| Cohort 2: TNBC Cancer | 19.0 Percentage of participants |
|---|
| Cohort 3: Squamous NSCLC | 4.3 Percentage of participants |
|---|
| Cohort 4: Non-squamous NSCLC | 16.3 Percentage of participants |
|---|
| Cohort 5: Head and Neck Cancer | 23.9 Percentage of participants |
|---|
| Cohort 7: EAC | 9.5 Percentage of participants |
|---|
Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
Up to 12.85 months · Percentage of participants
| Cohort 9: HNSCC | 39.0 Percentage of participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.