Pembrolizumab + Radiation for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBrian C Baumann

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 patients with 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.

Research Team

Brian C Baumann

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with high-grade non-muscle invasive bladder cancer, who've had tumors removed and are recommended for cystectomy but may not be operable. They should have no nodal disease or metastasis, no pure squamous cell or adenocarcinoma of the bladder, nor neuroendocrine features.

Inclusion Criteria

My cancer does not have neuroendocrine features.

My bladder cancer re-evaluation shows no muscle invasion.

I have a specific type of bladder cancer that has not spread, and surgery was recommended.

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Treatment Details

Interventions

Cisplatin (Chemotherapy)
Fluorouracil (Chemotherapy)
Gemcitabine (Chemotherapy)
Mitomycin (Chemotherapy)
Pembrolizumab (Checkpoint Inhibitor)
Radiation Therapy (Radiation)

Trial OverviewThe PARRC Trial is comparing pembrolizumab plus radiation therapy to standard chemotherapy (cisplatin, gemcitabine, fluorouracil or mitomycin) with radiation in treating non-muscle invasive bladder cancer. It aims to see if pembrolizumab can better help the immune system attack cancer cells.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (Pembrolizumab and radiation)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients also undergo optional urine sample collection on study.

Group II: Arm 1 (Chemotherapy and radiation)Active Control9 Interventions

Patients receive one of the following chemotherapy regimens per physicians choice: 1) cisplatin IV once per week for 4 weeks, 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22, and 25, or 3) mitomycin IV on day 1 and 5-fluorouracil IV continuously over 120 hours on days 1-5 and 16-20. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients also undergo optional urine sample collection on study.