Phase II Study of Immunoradiotherapy With Pembrolizumab and Radiation After Neoadjuvant Therapy to Preserve the Bladder in Muscle Invasive Bladder Cancer

What this Trial Is About

This research evaluates the combination of pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to prevent the need for surgery to remove the bladder cystectomy following standard chemotherapy that aims to shrink or eliminate the tumor. This phase II trial focuses on bladder preservation and improving survival without bladder removal in this patient group. Participants receive photon beam radiation therapy daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given intravenously on the first day of each 21-day cycle, for up to 18 cycles totaling 12 months, including the prior chemotherapy phase. Before and during treatment, patients undergo tissue collection via transurethral resection of bladder tumor TURBT, imaging scans such as CT, MRI, or PET, as well as cystoscopy and urine and blood tests. Throughout the study, patients are monitored for treatment effects, tumor recurrence, metastasis, and overall survival, with assessments of side effects and patient-reported symptoms related to gastrointestinal, urinary, and sexual function. After treatment, follow-up visits occur every 26 weeks until two years, then annually up to five years. Specimens are also collected for future research. The main outcome measured is bladder intact event-free survival within three years after registration.

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial