Phase I Study Evaluating Safety of Combined Immunotherapy and Radiation Therapy for Bladder Cancer

What this Trial Is About

Researchers are evaluating the safety of giving immunotherapy and radiation therapy at the same time as additional treatment for patients with urothelial bladder cancer. This Phase I study focuses on assessing the side effects, especially acute toxicity, that may happen when these two treatments are combined after surgery. The goal is to understand if this combined approach is safe for patients who have had bladder cancer surgery. Participants will receive standard immunotherapy and radiation therapy treatments together. Radiation therapy will start between 12 and 18 weeks after beginning adjuvant nivolumab and will continue for about 6 weeks. The study treatment involves receiving both therapies concurrently, which is the main research focus. Patients will continue to have standard care and follow-up during the study. During the study, patients will be monitored closely with standard examinations and imaging to assess safety within 18 weeks from the start of radiation therapy. Researchers will track any side effects and acute toxicities related to the combined treatments. Participation involves regular visits for treatments and evaluations, including scans and physical exams, to ensure ongoing safety and response to therapy. The study is expected to continue until April 2027.

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer