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NCT04225117 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
A Phase 2 study of Locally Advanced or Metastatic Malignant Solid Tumors, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 2
- Development phase
- 329
- Enrollment target
- 20
- Study locations
NCT04225117: Active Phase 2 study of Locally Advanced or Metastatic Malignant Solid Tumors, sponsored by Astellas Pharma Global Development.
NCT04225117 is a Phase 2 study of Locally Advanced or Metastatic Malignant Solid Tumors that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 329 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (147% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225117, a Phase 2 study of Locally Advanced or Metastatic Malignant Solid Tumors, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 329 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG enfortumab vedotin
Study Locations (20)
Florida
- Florida Cancer Specialists - Fort Myers
- Florida Cancer Specialists - Tallahassee
- Florida Cancer Specialists - West Palm Beach
Georgia
- Piedmont Hospital - Atlanta
- Northside Hospital - Atlanta
Illinois
- Northwestern University Medical Center - Chicago
- University of Chicago - Chicago
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Hospital - Detroit
Arizona
- Arizona Oncology - Tucson
California
- University of California - San Francisco - San Francisco
Colorado
- University of Colorado - Aurora
Indiana
- Indiana University Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04225117 still lists
NCT04225117 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (147% higher).
The record links to 1 condition, with Locally Advanced or Metastatic Malignant Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT04225117 names 20 study sites across 15 states, led by Florida, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT04225117 about?
NCT04225117 is a clinical study titled "A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)". 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 e...
What is the current status of trial NCT04225117?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 329 participants. The study started on 2020-03-09. Estimated completion is 2026-09-30.
What conditions does trial NCT04225117 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Malignant Solid Tumors.
What interventions are being tested in trial NCT04225117?
The interventions under investigation include: pembrolizumab (DRUG), enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT04225117?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04225117 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Advanced or Metastatic Malignant Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04225117's enrollment target sits among peer trials
329 146th of 2000 higher than 1,855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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