Summary
Study is closed to new patients. This is a Phase III double blinded study that is studying male and female participants at least 18 years of age with MIBC clinical stage T2-T4aN0M0 who elect to receive CRT.
Description
The Primary Objectives are : - To compare bladder intact event-free survival in participants from Arm A (pembrolizumab + chemoradiotherapy) and Arm B (placebo + chemoradiotherapy), based on cystoscopy, biopsy with central pathology review (if applicable), urine cytology and radiographic assessment by blinded independent central review
with the Hypothesis of : Pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
Approximately 636 participants will be randomized in a 1:1 ratio to receive either pembrolizumab + CRT or placebo + CRT.
Principal Investigator
Study Coordinator
Research Contact
Jordan Campanelli - jordan.campanelli@vandaliahealth.org