Actively Recruiting
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 )
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-11
390
Participants Needed
1
Research Sites
302 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
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.
CONDITIONS
Official 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
- Submission of tissue showing muscle-invasive urothelial cancer for clinical staging at baseline
- Eligible for and willing to receive chemoradiotherapy with one of the protocol-specified radiosensitizing chemotherapy regimens
- Fit for systemic therapy and elect bladder preservation, including those ineligible for or who have chosen 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), urothelial carcinoma or variant histology outside the bladder within 24 months before randomization except certain upper urinary tract conditions if nephrectomy done
- Prior systemic treatment, chemoradiation, or radiation for muscle-invasive or non-muscle-invasive bladder cancer
- Previous pelvic radiation for any reason
- Inadequate bladder function
- Other active cancers diagnosed within 3 years prior to randomization
- Previous treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
- Previous treatment with PD-1 or PD-L1 inhibitors
- Uncontrolled diabetes
- Currently receiving systemic antimicrobial treatment for active infection at randomization (routine prophylaxis allowed)
- Known active hepatitis B or C, or HIV infection
- Major surgery within 4 weeks prior to randomization
- Known severe (Grade 3 or higher) hypersensitivity to enfortumab vedotin excipients
- Known genetic disorders linked to radiosensitivity (e.g., ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)
- Active keratitis or corneal ulcerations
- History of autoimmune disease requiring systemic treatment in past 2 years
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonitis on screening chest CT
- Prior allogeneic stem cell or solid organ transplant
- Live attenuated vaccine within 30 days before randomization
AI-Screening
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Trial Site Locations
Total: 1 location
1
Texas Oncology
Austin, Texas, United States, 78705
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
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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