Trial · NCT07566156
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
NCT07566156, Phase 3, Recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309). Trials, record NCT07566156. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07566156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
- NCT number
- NCT07566156
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 390 participants, estimated
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Urothelial Cancer, Urinary Bladder Neoplasms
- Interventions
- Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy, Cisplatin, Fluorouracil, Mitomycin C, Gemcitabine, Pembrolizumab
- First posted
- 2026-05-04
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR) | Up to approximately 45.5 months | 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. |
| Primary | Overall Survival (OS) | Up to approximately 60 months | Time from randomization to death due to any cause. |
| Secondary | Bladder-intact Event Free Survival (BI-EFS) by Investigator | Up to approximately 45.5 months | BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment, histologically confirmed recurrent MIBC, disease progression, cystectomy, or death from any cause. |
| Secondary | Complete clinical response (cCR) rate by Blinded Independent Central Review (BICR) and Investigator | Up to approximately 60 months | cCR is defined as no radiographic evidence of residual or metastatic disease on imaging, negative cystoscopy, negative pathology except for low-grade Ta, and negative urine cytology. |
| Secondary | Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) and Investigator | Up to approximately 60 months] | Time from randomization to radiologically or pathologically confirmed distant metastasis, or death due to any cause, whichever occurs first. |
| Secondary | Time to Cystectomy | Up to approximately 60 months | The time from randomization to cystectomy. |
| Secondary | Disease Free Survival (DFS) by Blinded Independent Central Review (BICR) and Investigator | Up to approximately 60 months | The time from cCR to local recurrence or distant metastases, a second primary bladder cancer, or death due to any cause, whichever occurs first. |
| Secondary | Cystectomy Free Survival (CFS) | Up to approximately 60 months | The time from randomization to cystectomy or death due to any cause, whichever occurs first. |
| Secondary | Number of Participants with Treatment Emergent Adverse Event (TEAE) | From start of study treatment up to 30 days after last dose of study drug (approximately up to 1.1 years) | An AE is any untoward medical occurrence in a participant who receives a study treatment without regard to possibility of causal relationship. Treatment-emergent are events between the first dose of study treatment and up to 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Number of Participants with Serious TEAEs | From start of treatment up to 90 days after the last dose of study treatment (approximately up to 1.3 years) | An SAE is any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07566156
GET https://conductscience.org/api/trials/v1/NCT07566156/registered