drugset / Trial / NCT06770582

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

NCT06770582

Phase 2 Recruiting 160 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.

Timeline

Start
2025-06-03
Primary completion
2032-02-01
Completion
2032-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified Intravenous
Comparator Gemcitabine Small molecule Intravenous
Comparator Mitomycin C Other / unclassified Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous
Comparator fluorouracil Small molecule Intravenous