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

Recruiting now · Phase 3

Conditions studied: Urothelial Cancer, Urinary Bladder Neoplasms

In brief

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.

Key facts

Study ID

NCT07566156

Run by

Astellas Pharma Global Development, Inc.

People needed

390

Starts

2026-05-11

Expected to finish

2032-02-29

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Samsun Clinic - Ridley-Tree Cancer Center — Santa Barbara, California, United States (enrolling)
• Rocky Mountain Cancer Center — Aurora, Colorado, United States (enrolling)
• Medical Oncology Hematology Consultants — Newark, Delaware, United States (enrolling)
• Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• Williamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States (enrolling)
• Compass Oncology - West — Tigard, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology — Austin, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas — Tyler, Texas, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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