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Enfortumab Vedotin and Pembrolizumab for Muscle-Invasive Bladder Cancer

This study is testing a combination of two drugs, enfortumab vedotin and pembrolizumab, for people with muscle-invasive bladder cancer (cancer that has grown into the bladder muscle but not spread elsewhere). This new treatment approach will be compared to the standard treatment, which is concurrent chemoradiotherapy (chemotherapy and radiation given at the same time). The goal is to see if the new combination can help preserve the bladder. The study is looking for about 390 participants aged 18 and older, of all genders, who have not had prior treatment for this type of bladder cancer. Success will be measured by how long people live without their bladder being removed or other bladder-related issues, and overall survival.

Study design
This interventional study compares two treatment approaches for muscle-invasive bladder cancer. It aims to enroll 390 participants.
What's involved
Participants will receive enfortumab vedotin and pembrolizumab for up to 9 or 17 cycles, respectively, or concurrent chemoradiotherapy for up to 6.5 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for bladder-intact event-free survival for up to approximately 45.5 months and overall survival for up to approximately 60 months.

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NCT07566156

Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Astellas Pharma Global Development, Inc.
~390 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:Enfortumab vedotinConventional RadiotherapyHypofractionated RadiotherapyCisplatinFluorouracilMitomycin C

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR)
Measured over Up to approximately 45.5 months
+1 more outcome measured

Conditions

Urothelial Cancer
Urinary Bladder Neoplasms

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT07566156

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Compass Oncology - West

    Tigard, Oregonno site contact published

    Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indianano site contact published

    Recruiting

  • Illinois Cancer Specialists

    Niles, Illinoisno site contact published

    Recruiting

  • Medical Oncology Hematology Consultants

    Newark, Delawareno site contact published

    Recruiting

  • Missouri Cancer Associates

    Columbia, Missourino site contact published

    Recruiting

  • Oncology Hematology Care Clinical Trials, LLC

    Fairfield, Ohiono site contact published

    Recruiting

  • Rocky Mountain Cancer Center

    Aurora, Coloradono site contact published

    Recruiting

  • Samsun Clinic - Ridley-Tree Cancer Center

    Santa Barbara, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Zejing Wang, MD/PhD · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

Inclusion

Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline
Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens
Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion

Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta/T1/CIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy
Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC
Prior pelvic radiation for any reason
Inadequate bladder function
Other active malignancies within 3 years prior to randomization
Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)
Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor
Uncontrolled diabetes
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted
Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection
Received major surgery (defined as requiring general anesthesia and \>24 hour inpatient hospitalization) within 4 weeks prior to randomization
Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)
Active keratitis or corneal ulcerations
History of autoimmune disease that has required systemic treatment in the past 2 years
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic stem cell or solid organ transplant
Received a live attenuated vaccine within 30 days prior to randomization

What this trial measures

  • 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.

  • Overall Survival (OS)Up to approximately 60 months

    Time from randomization to death due to any cause.