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A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Protocol No
Principal Investigator
Ariel Nelson
The purpose of this study is to: * Test the safety of the study drug, Pembrolizumab, when given with chemoradiotherapy (CRT). CRT is a combination of chemotherapy and radiation therapy. * See if Pembrolizumab and CRT controls muscle-invasive bladder cancer and helps patients live longer, compared to CRT alone. * See how well the body handles Pembrolizumab. * See if Pembrolizumab and CRT helps participants have a better quality of life, compared to CRT alone. Pembrolizumab has been approved for patients with certain types of bladder cancer. However, it has not been approved for your type of bladder cancer. Getting Pembrolizumab in combination with CRT for muscle-invasive bladder cancer (MIBC) is considered experimental. We don't know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for muscle invasive bladder cancer in the future.
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
Participating Institutions
Froedtert Hospital