Keynote B15 - EV/Pembro vs GEM/CIS in muscle-invasive bladder cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental combination of two drugs, enfortumab vedotin (EV) and pembrolizumab, is a safe and effective treatment for your cancer. EV is an approved treatment for bladder cancer, and pembrolizumab is an immunotherapy that is approved to treat other cancers.

What is the Condition Being Studied?

Muscle-Invasive Bladder Cancer

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with muscle-invasive bladder cancer
- Are eligible for radical prostatectomy and/or pelvic lymph node dissection
- Have never received chemotherapy, immunotherapy, or radiation for bladder cancer

For more information about who can join this study, please contact the study team at 919-681-7460.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- Group A will take the study drugs, EV and pembrolizumab
-- Group B will take the chemotherapy combination of gemcitabine and cisplatin
- Have surgery to remove your bladder after about 12 weeks of drug therapy

Participants assigned to Group A will continue to take EV and pembrolizumab after surgery.

Study Details

Full Title
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
Christopher Hoimes
Protocol Number
IRB: PRO00107815
NCT: NCT04700124
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698