OncoMatch/Clinical Trials/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
Is NCT06770582 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for non-muscle invasive bladder urothelial carcinoma.
Treatment: Cisplatin · Fluorouracil · Gemcitabine · Mitomycin · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage STAGE I AJCC V8 (AJCC v8)
Grade: high-grade
T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intravesical therapy (Bacillus Calmette-Guerin, intravesical chemotherapy) — induction
at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available
Cannot have received: systemic chemotherapy
No prior systemic chemotherapy or immunotherapy for urothelial carcinoma
Cannot have received: immunotherapy
No prior systemic chemotherapy or immunotherapy for urothelial carcinoma
Cannot have received: anti-PD-1 therapy
No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
Cannot have received: anti-PD-L1 therapy
No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
Cannot have received: anti-PD-L2 therapy
No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
Cannot have received: anti-CTLA-4 therapy
No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
Cannot have received: T-cell co-stimulation targeting therapy
No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
Cannot have received: pelvic radiation therapy
No history of pelvic radiation therapy
Lab requirements
Blood counts
ANC ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl (transfusion or other intervention to achieve Hgb ≥ 9 g/dl is acceptable)
Kidney function
creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels > 1.5 × institutional ULN
Liver function
Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome); AST and ALT ≤ 3 x institutional ULN
Cardiac function
Recovered from acute cardiac illness; New York Heart Association Functional Classification II or better (NYHA III/IV not eligible)
ANC ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl; creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × ULN or creatinine levels > 1.5 × institutional ULN; Total bilirubin ≤ institutional ULN (Not applicable to patients with known Gilbert's syndrome); AST and ALT ≤ 3 x institutional ULN; Recovered from acute cardiac illness; NYHA II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- AIS Cancer Center at San Joaquin Community Hospital · Bakersfield, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- Shaw Cancer Center · Edwards, Colorado
- Helen F Graham Cancer Center · Newark, Delaware
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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