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Immunotherapy or Chemotherapy with Radiation for Bladder Cancer

This study is testing two approaches for non-muscle invasive bladder cancer that would otherwise require surgery to remove the bladder. One approach combines the immunotherapy drug pembrolizumab with radiation therapy. Immunotherapy helps your body's immune system fight cancer. The other approach uses standard chemotherapy drugs like cisplatin, gemcitabine, or 5-fluorouracil, along with radiation therapy. Chemotherapy works by stopping cancer cells from growing and spreading. Radiation therapy uses high-energy rays to kill cancer cells. Researchers want to see which treatment leads to better bladder-intact event-free survival (meaning the bladder remains and the cancer doesn't return or spread) and better quality of life. You may be eligible if you have T1 high-grade non-muscle invasive bladder cancer without spread to lymph nodes or other parts of the body. The study aims to enroll 160 participants.

Study design
This is an interventional study comparing two different treatment arms. Participants will be randomly assigned to receive either immunotherapy with radiation or chemotherapy with radiation.
What's involved
You would undergo blood and urine sample collection, and CT scans. You would also receive either intravenous (IV) chemotherapy or immunotherapy and radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Your bladder-intact event-free survival and quality of life will be measured for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~160 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCisplatinComputed TomographyFluorouracilGemcitabineMagnetic Resonance Imaging

At a glance

Recruiting sites
135 of 138 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bladder intact event-free survival (BIEFS)
Measured over Up to 5 years
+1 more outcome measured

Conditions

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

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NCT06770582

Where you'd take part

This study runs at 138 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, Californiastudy coordinator listed

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginiastudy coordinator listed

    Recruiting

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginiastudy coordinator listed

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginiastudy coordinator listed

    Recruiting

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginiastudy coordinator listed

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowastudy coordinator listed

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michiganstudy coordinator listed

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brian C Baumann · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
479-872-8100
Email the study team

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Eligibility criteria

Inclusion

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.
NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
High grade T1 disease history that must meet at least ONE of the three criteria below:
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.
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)
Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)
Restaging TURBT must be performed and must meet ALL of the following criteria below:
If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.
All grossly visible papillary tumors must be removed
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
No pure squamous cell carcinoma or adenocarcinoma of the bladder
No neuroendocrine (small or large cell) features
No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)
No prostatic urethral involvement
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 9 g/dl is acceptable)
Adequate renal function defined as 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
Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
All adverse events of their most recent therapy/intervention must have resolved to \< grade 3 or returned to baseline prior to registration
No history of pelvic radiation therapy
No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed
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
No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \[COVID\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible
Patients must have recovered from acute cardiac illness
New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
No active infection requiring IV antibiotics
No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis
No history of allogeneic bone marrow transplant or prior solid organ transplant
No active tuberculosis
No evidence of hydronephrosis
No history of upper tract urothelial carcinoma within 24 months of registration
No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable
No history of allergic reaction to the drug excipients

What this trial measures

  • Bladder intact event-free survival (BIEFS)Up to 5 years

    Defined as time free of histologically proven recurrent T1-T4 recurrence, clinical evidence of nodal or distant metastasis, radical cystectomy (either for disease progression or due to toxicity), or death from any cause. Analysis will consist of estimation of the BIEFS curves via the Kaplan-Meier estimator and testing of the primary hypothesis using the stratified logrank test (one-sided). Additionally, the Cox proportional hazards model will be used to estimate the hazard ratio adjusting for stratification variables and any other baseline covariates that demonstrate any degree of imbalance by treatment arm.

  • Global quality of lifeUp to 5 years

    Assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) global quality of life domain.