Actively Recruiting
Enfortumab Vedotin Plus Pembrolizumab Versus Concurrent Chemoradiotherapy in Adults With Muscle-Invasive Bladder Cancer Not Undergoing Cystectomy
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-08
390
Participants Needed
9
Research Sites
100 weeks
Total Duration
On this page
Sponsors
A
Astellas Pharma Global Development, Inc.
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well two drugs, enfortumab vedotin and pembrolizumab, work together to preserve the bladder in patients with muscle-invasive bladder cancer that has not spread beyond the bladder. This study compares this drug combination to the standard treatment of chemoradiotherapy commonly used for this cancer type. The trial is a phase 3 study focused on adults who are either not eligible for or have chosen not to undergo bladder removal surgery (cystectomy). Participants will receive either the combination of enfortumab vedotin given as an IV infusion on Days 1 and 8 of every 3-week cycle for up to 9 cycles along with pembrolizumab given as an IV infusion on Day 1 of every 3-week cycle for up to 17 cycles, or they will receive standard concurrent chemoradiotherapy. The chemoradiotherapy involves radiation delivered over 6.5 weeks, potentially with chemotherapy drugs such as cisplatin, fluorouracil, mitomycin C, or gemcitabine according to protocol regimens. Treatment continues until the maximum number of cycles or weeks is reached, or a reason for stopping the study treatment occurs. During the study, participants will be closely monitored through regular clinical assessments including scans and laboratory tests. Researchers will measure outcomes such as bladder-intact event-free survival and overall survival up to about 45.5 to 60 months. Additional measures include response rates, metastasis-free survival, time to bladder removal surgery, disease-free survival, and safety by tracking adverse events during and after treatment. The total follow-up can extend up to five years to understand the long-term effects of the treatments.
CONDITIONS
Brief Title
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
- Tissue with muscle-invasive urothelial cancer 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 those ineligible for or who have elected not to undergo cystectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
You will not qualify if you...
- Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal carcinoma in situ (CIS), or urothelial carcinoma at any site outside the bladder within 24 months prior to randomization except certain upper urinary tract cases
- Prior systemic treatment, chemoradiation, or radiation for MIBC or non-muscle invasive bladder cancer (NMIBC)
- Prior pelvic radiation for any reason
- Inadequate bladder function
- Other active malignancies within 3 years prior to randomization
- Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
- Prior treatment with PD-1 or PD-L1 inhibitors
- Uncontrolled diabetes
- Active infection requiring systemic antimicrobial treatment at randomization (routine prophylaxis permitted)
- Known active hepatitis B, hepatitis C, or HIV infection
- Major surgery requiring general anesthesia and hospitalization over 24 hours within 4 weeks prior to randomization
- Severe hypersensitivity to enfortumab vedotin excipients
- Genetic disorders causing radiosensitivity
- Active keratitis or corneal ulcerations
- Autoimmune diseases requiring systemic treatment in past 2 years
- History or evidence of pneumonitis or related lung conditions
- Prior allogeneic stem cell or solid organ transplant
- Live attenuated vaccine within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 cycles of enfortumab vedotin (each 3 weeks) and up to 17 cycles of pembrolizumab (each 3 weeks) or up to 6.5 weeks for concurrent chemoradiotherapy, whichever occurs first.
Participants receive either enfortumab vedotin plus pembrolizumab or concurrent chemoradiotherapy as treatment for muscle-invasive bladder cancer.
Multiple visits for IV infusions and radiotherapy sessions over the treatment period
Duration - Up to approximately 60 months
Participants are monitored for safety and long-term outcomes after completing treatment.
Periodic visits over several years for survival and disease status assessments
Trial Site Locations
Total: 9 locations
1
Samsun Clinic - Ridley-Tree Cancer Center
Santa Barbara, California, United States, 93105
Actively Recruiting
2
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
Actively Recruiting
3
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Actively Recruiting
4
Williamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Actively Recruiting
5
Compass Oncology - West
Tigard, Oregon, United States, 97223
Actively Recruiting
6
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Texas Oncology
Austin, Texas, United States, 78705
Actively Recruiting
8
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
9
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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