Trial Watch: Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) (NCT07566156) as a Phase 3 interventional cancer study. The registry status is Recruiting, with the record last updated 2026-09-11.
Study snapshot: Phase 3; Recruiting; planned enrollment 390. Conditions listed: Urothelial Cancer, Urinary Bladder Neoplasms. A primary outcome listed by the registry is: Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR).
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 18 Years and older with Urothelial Cancer, Urinary Bladder Neoplasms who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Not specified in this summary
- Sample size
- 390
- Primary outcome
- Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as Astellas Pharma Global Development, Inc.. Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Country or region not specified
- Status
- Investigational
- Last verified
- 2026-09-11
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-09-11
Primary evidence supporting this story
- ClinicalTrials.gov — NCT07566156 (opens in a new tab) (Clinical-trial registry) NCT07566156 Primary source NCT07566156
ClinicalTrials.gov — NCT07566156. NCT07566156.
Last reviewed
Trial Watch: Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
https://cancerdiscoveries.com/discoveries/trial-watch-enfortumab-vedotin-in-combination-with-pembrolizumab-vs-concurrent-chemoradiotherapy-ccrt-in-people-with-muscle-invasive-bladder-cancer-ev-309/
Research type: Registered later-phase trial
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT07566156 — https://clinicaltrials.gov/study/NCT07566156 (NCT07566156)
Date verified: 2026-09-11
Correction status: No correction or retraction