Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
Public ClinicalTrials.gov record NCT07566156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.
Study identification
- NCT ID
- NCT07566156
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 390 participants
Conditions and interventions
Conditions
Interventions
- Enfortumab vedotin Drug
- Conventional Radiotherapy Radiation
- Hypofractionated Radiotherapy Radiation
- Cisplatin Drug
- Fluorouracil Drug
- Mitomycin C Drug
- Gemcitabine Drug
- Pembrolizumab Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 10, 2026
- Primary completion
- Mar 30, 2030
- Completion
- Feb 28, 2032
- Last update posted
- Aug 5, 2026
2026 – 2032
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Samsun Clinic - Ridley-Tree Cancer Center | Santa Barbara | California | 93105 | Recruiting |
| Rocky Mountain Cancer Center | Aurora | Colorado | 80012 | Recruiting |
| Medical Oncology Hematology Consultants | Newark | Delaware | 19713 | Recruiting |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | Recruiting |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46825 | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | Recruiting |
| Williamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | Recruiting |
| Compass Oncology - West | Tigard | Oregon | 97223 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Texas Oncology | Austin | Texas | 78705 | Recruiting |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07566156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07566156 live on ClinicalTrials.gov.