Study on Adding Pembrolizumab to Radiation Therapy Compared to Usual Chemotherapy for Bladder Cancer

Program Overview

This study is comparing two treatment approaches for non-muscle invasive bladder cancer. One group will receive the immunotherapy drug pembrolizumab along with radiation therapy. The other group will receive chemotherapy drugs like cisplatin, gemcitabine, 5-fluorouracil, or mitomycin-C along with radiation therapy. The goal is to see if pembrolizumab with radiation can better help the immune system attack cancer cells and prevent them from growing and spreading, compared to the usual chemotherapy with radiation.

Description

The main goal of this study is to compare how long patients can live without their bladder cancer returning or worsening. Other goals include checking how well the cancer responds to treatment, how long patients live without the cancer spreading, and overall survival rates. The study will also look at the quality of life of patients and any side effects they experience.

Participants will be randomly assigned to one of two groups:

• Group 1: Will receive chemotherapy (cisplatin, gemcitabine, or mitomycin-C with 5-fluorouracil) along with radiation therapy. Chemotherapy will be given through an IV, and radiation will be given over several weeks. Patients will also have regular scans and blood tests.

• Group 2: Will receive pembrolizumab through an IV every six weeks for up to nine cycles, along with radiation therapy over several weeks. Patients will also have regular scans and blood tests.

After completing the treatment, patients will have follow-up visits every few months for the first two years, then less frequently for up to five years to monitor their health and any signs of cancer returning.

Eligibility Criteria

Locations