Comparing Pembrolizumab Plus Radiation to Chemotherapy Plus Radiation for High-Grade T1 Bladder Cancer Treatment

What this Trial Is About

Researchers are comparing two treatment approaches for patients with high-grade T1 non-muscle invasive bladder cancer. This phase II trial evaluates pembrolizumab combined with radiation therapy against standard chemotherapy regimens plus radiation. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells, while chemotherapy drugs work to kill or stop tumor cells from growing and spreading. Radiation therapy uses high-energy rays or particles to destroy cancer cells and shrink tumors. Participants are randomly assigned to one of two treatment groups. One group receives chemotherapy chosen by their doctor, which may include cisplatin, gemcitabine, or a combination of mitomycin and 5-fluorouracil, along with radiation therapy delivered over 4 to 7 weeks. The other group receives pembrolizumab infusions every 6 weeks for up to 9 cycles, also combined with radiation therapy over the same period. Both groups undergo imaging scans and blood tests during treatment, with optional urine samples collected. After finishing treatment, participants are followed regularly for up to 10 years, with more frequent check-ups in the first 2 years and less frequent visits afterward. The study measures bladder-intact event-free survival and quality of life over 5 years, along with assessing tumor response, disease control, survival rates, side effects, fatigue, and other quality of life factors. Researchers aim to understand the long-term effects of these treatments and monitor patient safety throughout the study.

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial