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.
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.
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.