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

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.

Trial Details

NCT ID

NCT07566156

Phase

PHASE3

Sponsor

Astellas Pharma Global Development, Inc.

Status

RECRUITING

Cancer Type

Non-Muscle-Invasive Bladder Cancer

Interventions

Enfortumab vedotin
Conventional Radiotherapy
Hypofractionated Radiotherapy
Cisplatin
Fluorouracil
Mitomycin C

Locations (sample)

Santa Barbara, California, United States|34.42083,-119.69819
Newark, Delaware, United States|39.68372,-75.74966
Niles, Illinois, United States|42.01892,-87.80284
Eugene, Oregon, United States|44.05207,-123.08675
Tigard, Oregon, United States|45.43123,-122.77149

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Muscle-Invasive Bladder Cancer Trials on Trialify →