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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06770582

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood and urine sample collection
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT
  • Fluorouracil (Drug)
    Given IV
  • Gemcitabine (Drug)
    Given IV
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Mitomycin (Drug)
    Given IV
  • Pembrolizumab (Biological)
    Given IV
  • Questionnaire Administration (Other)
    Ancillary studies
  • Radiation Therapy (Radiation)
    Undergo radiation therapy

Eligibility criteria

Inclusion Criteria: * 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

Conditions

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

Locations

  • Banner University Medical Center - Tucson — Tucson, Arizona, United States
  • Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas, United States
  • Highlands Oncology Group - Rogers — Rogers, Arkansas, United States
  • Highlands Oncology Group — Springdale, Arkansas, United States
  • AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • Los Angeles General Medical Center — Los Angeles, California, United States
  • USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, 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
  • Mount Sinai Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
  • Mount Sinai Medical Center — Miami Beach, Florida, United States
  • Grady Health System — Atlanta, Georgia, United States
  • Emory Proton Therapy Center — Atlanta, Georgia, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
  • Rush MD Anderson Cancer Center — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Crossroads Cancer Center — Effingham, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • Carle BroMenn Medical Center — Normal, Illinois, United States
  • Carle Cancer Institute Normal — Normal, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Springfield Memorial Hospital — Springfield, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • Mary Greeley Medical Center — Ames, Iowa, United States
  • McFarland Clinic - Ames — Ames, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • Mercy Cancer Center-West Lakes — Clive, Iowa, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • Broadlawns Medical Center — Des Moines, Iowa, United States
  • Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • UI Healthcare Mission Cancer and Blood - Pella — Pella, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • The Iowa Clinic PC — West Des Moines, Iowa, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • Louisiana Hematology Oncology Associates LLC — Baton Rouge, Louisiana, United States
  • Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
  • Mary Bird Perkins Cancer Center - Gonzales — Gonzales, Louisiana, United States
  • Mary Bird Perkins Cancer Center - Metairie — Metairie, Louisiana, United States
  • Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan, United States
  • Trinity Health Medical Center - Brighton — Brighton, Michigan, United States
  • Trinity Health Medical Center - Canton — Canton, Michigan, United States
  • Chelsea Hospital — Chelsea, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • West Michigan Cancer Center — Kalamazoo, Michigan, United States
  • University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
  • Michigan Healthcare Professionals Pontiac — Pontiac, Michigan, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
  • University of Michigan Health - West — Wyoming, Michigan, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
  • Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Essentia Health Saint Mary's Medical Center — Duluth, Minnesota, United States
  • Miller-Dwan Hospital — Duluth, Minnesota, United States
  • Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
  • Essentia Health Sandstone — Sandstone, Minnesota, United States
  • Essentia Health Virginia Clinic — Virginia, Minnesota, United States
  • Saint Francis Medical Center — Cape Girardeau, Missouri, United States
  • Parkland Health Center - Farmington — Farmington, Missouri, United States
  • University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - North — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
  • Lake Regional Hospital — Osage Beach, Missouri, United States
  • Sainte Genevieve County Memorial Hospital — Sainte Genevieve, Missouri, United States
  • Mercy Hospital South — St Louis, Missouri, United States
  • Missouri Baptist Medical Center — St Louis, Missouri, United States
  • Mercy Hospital Saint Louis — St Louis, Missouri, United States
  • Missouri Baptist Sullivan Hospital — Sullivan, Missouri, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • Riverside Methodist Hospital — Columbus, Ohio, United States
  • Grant Medical Center — Columbus, Ohio, United States
  • Doctors Hospital — Columbus, Ohio, United States
  • Dublin Methodist Hospital — Dublin, Ohio, United States
  • OhioHealth Mansfield Hospital — Mansfield, Ohio, United States
  • OhioHealth Marion General Hospital — Marion, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Christiana Care Health System-Concord Health Center — Chadds Ford, Pennsylvania, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Geisinger Cancer Center Dickson City — Dickson City, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Horizon — Farrell, Pennsylvania, United States
  • UPMC Cancer Centers - Arnold Palmer Pavilion — Greensburg, Pennsylvania, United States
  • Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
  • Geisinger Medical Oncology-Lewisburg — Lewisburg, Pennsylvania, United States
  • UPMC Cancer Center - Monroeville — Monroeville, Pennsylvania, United States
  • UPMC Hillman Cancer Center - Monroeville — Monroeville, Pennsylvania, United States
  • UPMC Hillman Cancer Center - New Castle — New Castle, Pennsylvania, United States
  • UPMC-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Saint Margaret — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Passavant Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Northwest — Seneca, Pennsylvania, United States
  • UPMC Cancer Center-Washington — Washington, Pennsylvania, United States
  • UPMC Washington Hospital Radiation Oncology — Washington, Pennsylvania, United States
  • Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
  • Central Vermont Medical Center/National Life Cancer Treatment — Berlin Corners, Vermont, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Bon Secours Memorial Regional Medical Center — Mechanicsville, Virginia, United States
  • Bon Secours Saint Francis Medical Center — Midlothian, Virginia, United States
  • Bon Secours Saint Mary's Hospital — Richmond, Virginia, United States
  • Bon Secours Cancer Institute at Reynolds Crossing — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • VCU Community Memorial Health Center — South Hill, Virginia, United States
  • West Virginia University Healthcare — Morgantown, West Virginia, United States
  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton — Appleton, Wisconsin, United States
  • Duluth Clinic Ashland — Ashland, Wisconsin, United States
  • Northwest Wisconsin Cancer Center — Ashland, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield — Brookfield, Wisconsin, United States
  • Ascension Calumet Hospital-Chilton — Chilton, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon — Mequon, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus — Milwaukee, Wisconsin, United States
  • Ascension All Saints Hospital-Spring Street-Racine — Racine, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa — Wauwatosa, Wisconsin, United States
  • Marshfield Medical Center - Weston — Weston, Wisconsin, United States
  • The Research Institute of the McGill University Health Centre (MUHC) — Montreal, Quebec, Canada
  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) — Québec, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record