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)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)/CT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.
2. NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
3. High grade T1 disease history that must meet at least ONE of the three criteria below:
4. Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \[CIS\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and 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.
5. T1 with pathologic high-risk features (lymphovascular invasion \[LVI\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)
6. Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)
7. Restaging TURBT must be performed and must meet ALL of the following criteria below:
8. If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.
9. All grossly visible papillary tumors must be removed
10. Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial
11. No pure squamous cell carcinoma or adenocarcinoma of the bladder
12. No neuroendocrine (small or large cell) features

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (136 Sites)

• Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas
• Highlands Oncology Group - Rogers — Rogers, Arkansas
• Highlands Oncology Group — Springdale, Arkansas
• 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
• Medical Oncology Hematology Consultants PA — Newark, Delaware
• UF Health Cancer Institute - Gainesville — Gainesville, Florida
• Mount Sinai Medical Center — Miami Beach, Florida
• Grady Health System — Atlanta, Georgia
• Emory Proton Therapy Center — Atlanta, Georgia
• Emory University Hospital Midtown — Atlanta, Georgia
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Emory Saint Joseph's Hospital — Atlanta, Georgia
• Rush MD Anderson Cancer Center — Chicago, Illinois
• Carle at The Riverfront — Danville, Illinois
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois
• Decatur Memorial Hospital — Decatur, Illinois
• Carle Physician Group-Effingham — Effingham, Illinois
• Crossroads Cancer Center — Effingham, Illinois
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois
• Carle BroMenn Medical Center — Normal, Illinois
• Carle Cancer Institute Normal — Normal, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.