Lay Title: Perioperative EV plus Pembrolizumab vs. Neoadjuvant Chemotherapy for Cisplatin-Eligible muscle-invasive bladder cancer (MIBC)
Technical Title: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin for Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer
(KEYNOTE-B15 / EV-304)
Disease Type: This study is for patients with muscle-invasive bladder cancer who are planned to undergo surgery to remove the bladder (known as radical cystectomy or RC) and lymph nodes in the pelvic (known as pelvic lymph node dissection or PLND). The surgery is the standard of care, which means you would have it even if you were not in this trial.
Basic information: This trial is testing enfortumab vedotin (EV) + pembrolizumab (pembro) given before and after surgery in people with muscle-invasive bladder cancer (MIBC). EV works by binding to the surface of cancer cells, causing them to release chemicals that could lead to the death of tumor cells. Pembrolizumab blocks immune pathways in cancer cells that makes the body recognize them as foreign and attack them.
Getting pembro with EV before and after RC is considered investigational. The study will compare this investigational treatment with standard chemotherapy, gemcitabine + cisplatin, before and after surgery.
If you participate in this study, you will be randomized to one of two arms:
If you start study treatment and later decide not to have the surgery, you cannot continue taking trial drugs.
Research Procedures (not a complete list):
Before your surgery, you will come to clinic twice every 3 weeks for about 16 weeks (4 months) to receive treatment. You will return for an additional visit for pre-surgical imaging. You must undergo surgery to remove your bladder and lymph nodes within 6 weeks of your last treatment dose.
About 6 weeks after surgery, you will return to clinic for post-surgery scans. If you are in Arm A and your cancer has not gotten worse, you will re-start treatment for 39 weeks. If you are in Arm B, or you are in Arm A and your cancer gets worse, you will enter the follow-up period where you undergo safety visits and periodic scans.
Eligibility Criteria (not a complete list):
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