RecruitingPhase 2NCT06770582

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

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

Sponsor

National Cancer Institute (NCI)

Enrollment

160 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Stage I Bladder Cancer AJCC v8 Non-Muscle Invasive Bladder Urothelial Carcinoma Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing an immunotherapy drug called pembrolizumab given during radiation therapy versus the standard chemotherapy given during radiation therapy for people with high-risk bladder cancer who would otherwise need bladder removal surgery. **You may be eligible if...** - You have been diagnosed with high-grade, non-muscle-invasive bladder cancer (T1 stage, no evidence of lymph node or distant spread) - Your doctor has recommended bladder removal surgery (cystectomy) - You prefer to try to keep your bladder - You meet the health and organ function criteria **You may NOT be eligible if...** - Your bladder cancer has invaded the muscle layer or spread to lymph nodes or other organs - You have active autoimmune disease requiring systemic treatment - You have previously received immunotherapy drugs like PD-1/PD-L1 inhibitors - You are pregnant or breastfeeding - You have severe heart, liver, or kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT

DRUGFluorouracil

Given IV

DRUGGemcitabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGMitomycin

Given IV

BIOLOGICALPembrolizumab

Given IV

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONRadiation Therapy

Undergo radiation therapy

Locations(124)

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Shaw Cancer Center

Edwards, Colorado, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Grady Health System