A Phase 2 Study Assessing Radiation Therapy with Pembrolizumab Immunotherapy or the Usual Chemotherapy to Treat Bladder Cancer

Full Title

Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial) (NRG-GU014) (CIRB)

Purpose

Researchers are comparing two treatments for people with non-muscle invasive bladder cancer. If you take part in this study, you will be randomly assigned to get either:

  • Radiation therapy plus pembrolizumab immunotherapy. Pembrolizumab boosts the ability of the immune system to find and kill cancer cells.
  • Radiation therapy plus the usual chemotherapy. The usual chemotherapy includes the drugs cisplatin, gemcitabine, and 5-fluorouracil or mitomycin-C.

Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in these patients

Who Can Join

To join this study, there are a few conditions. You must:

  • Have high-grade non-muscle invasive bladder cancer.
  • Not have had prior chemotherapy or immunotherapy for bladder cancer or any radiation therapy to the pelvis.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Himanshu Nagar’s office at 212-639-6478.

Protocol

25-369

Phase

Phase II (phase 2)

Investigator

ClinicalTrials.gov ID

NCT06770582