A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Principal Investigator

Jacqueline Vuky

Study Purpose

This trial is testing enfortumab vedotin (EV) + pembrolizumab (pembro) given before and after surgery in people with muscle-invasive bladder cancer (MIBC). Pembro has been approved alone or with other drugs for people with bladder cancer. EV has been approved in the USA only for people with bladder cancer. Getting pembro with EV before and after surgery for MIBC is considered experimental. This trial will compare EV + pembro before and after surgery to gemcitabine + cisplatin before surgery. Gemcitabine and cisplatin are standard treatments for MIBC.

Medical Condition(s)

Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV 304)

Eligibility Criteria

Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer

Age Range

18 - 120

Healthy Volunteers Needed


Duration of Participation

The trial has 4 phases. The amount of time you will be in this trial depends on how long you are in each phase and how your cancer responds. If you can be in the trial, the next steps are the Pre-surgical and Post-surgical Phases. You will visit the trial site 2 times every 3 weeks for up 13 months. After you stop getting the trial drugs, you will enter the Follow-up Phase and may be asked to visit the clinic ever 6 to 12 weeks for up to 2 years. All participants may be contacted about every 12 weeks to check on their health. This will continue unless you choose to stop being in this trial or the trial is stopped.

Minors Included



Knight Cancer Clinical Trials


Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Recruitment End


Compensation Provided


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