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NCT07566156 · ClinicalTrials.gov registry record · Phase 3
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
NCT07566156: Recruiting Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT07566156 is a Phase 3 study that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 390 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07566156, a Phase 3 study, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
Study Summary
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.
Primary Outcome
BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment confirmed by BICR, histologically confirmed recurrent MIBC by BICR, disease progression by BICR, cystectomy, or death from any cause.
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Enfortumab vedotin
- RADIATION Hypofractionated Radiotherapy
- RADIATION Conventional Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2026-05-11 |
| Est. Completion | 2032-02-29 |
| Phase | Phase 3 |
What NCT07566156 shows while recruiting
NCT07566156 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT07566156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07566156 about?
NCT07566156 is a clinical study titled "Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)". 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 canc...
What is the current status of trial NCT07566156?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2026-05-11. Estimated completion is 2032-02-29.
What interventions are being tested in trial NCT07566156?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Enfortumab vedotin (DRUG), Hypofractionated Radiotherapy (RADIATION), Conventional Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT07566156?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07566156's enrollment target sits among peer trials
390 968th of 2000 higher than 1,029 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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