AzTrials
AzTrials

Non-Muscle Invasive Bladder Urothelial CarcinomaPhase 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

A Phase 2 study testing Biospecimen Collection, Cisplatin and Computed Tomography in people with Non-Muscle Invasive Bladder Urothelial Carcinoma and Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, run by National Cancer Institute (NCI) at 147 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cisplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
147 sitesin 2 countries
Study dates
3 Jun 2025to 1 Feb 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 41Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

147 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

147 sites in 2 countries

United States145 sites, 142 recruiting

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton

    Appleton, Wisconsin, 54915

    Site Public Contact, AWRI.inquiry@ascension.org

    Shannon Offerman

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Kamran Salari

    Recruiting

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

    Site Public Contact, 404-251-2854, allyson.anderson@emory.edu

    Kamran Salari

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Kamran Salari

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Kamran Salari

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Kamran Salari

    Recruiting

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 305-674-2625, yenrique@msmc.com

    Bruno R. Bastos

    Recruiting

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

    Site Public Contact, 661-323-4673

    Luis Mariscal

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Scott E. Delacroix

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Scott E. Delacroix

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Active, not recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Alexander P. Lukez

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    Sophia C. Kamran

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield

    Brookfield, Wisconsin, 53045

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Shannon Offerman

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Alexander P. Lukez

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Alexander P. Lukez

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Mary E. Westerman

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Christopher Luminais

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Dian Wang

    Recruiting

  • Ascension Calumet Hospital-Chilton

    Chilton, Wisconsin, 53014

    Site Public Contact, AWRI.inquiry@ascension.org

    Shannon Offerman

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Daniel H. Barnett

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Shaw Cancer Center

    Edwards, Colorado, 81632

    Site Public Contact, 970-569-7429

    Erin Schwab

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Adam Olson

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Active, not recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Active, not recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

    Site Public Contact, 479-872-8100, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010

    Daniel V. Araujo

    Recruiting

  • Mary Bird Perkins Cancer Center - Gonzales

    Gonzales, Louisiana, 70737

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Scott E. Delacroix

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Adam Olson

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Hyma Polimera

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shera Feinstein

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Eugene K. Lee

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Samir Narayan

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu

    Lauren A. Lukas

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451

    Lauren A. Lukas

    Recruiting

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Michael Siedow

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon

    Mequon, Wisconsin, 53097

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Shannon Offerman

    Recruiting

  • Mary Bird Perkins Cancer Center - Metairie

    Metairie, Louisiana, 70002

    Site Public Contact, 504-584-6990

    Scott E. Delacroix

    Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com

    Bruno R. Bastos

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus

    Milwaukee, Wisconsin, 53211

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Shannon Offerman

    Recruiting

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Adam Olson

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Joanna A. Kolodney

    Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam Olson

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Daniel H. Barnett

    Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Daniel H. Barnett

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Tyler Gunter

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shera Feinstein

    Recruiting

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

    Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com

    Jay W. Carlson

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Pella

    Pella, Iowa, 50219

    Site Public Contact, 515-282-2921, trials@missioncancer.com

    Seema Harichand-Herdt

    Recruiting

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Site Public Contact, 412-647-2811

    Adam Olson

    Recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Adam Olson

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Adam Olson

    Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-621-2334

    Adam Olson

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Adam Olson

    Recruiting

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Samir Narayan

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Ascension All Saints Hospital-Spring Street-Racine

    Racine, Wisconsin, 53405

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Shannon Offerman

    Recruiting

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

    Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org

    Joseph D. Pennington

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Alfredo I. Urdaneta

    Recruiting

  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Adam Olson

    Recruiting

  • VCU Community Memorial Health Center

    South Hill, Virginia, 23970

    Site Public Contact, nemer.elmouallem@vcuhealth.org

    Alfredo I. Urdaneta

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Jonathan J. Sackett

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Justin M. Haseltine

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UPMC Cancer Center-Washington

    Washington, Pennsylvania, 15301

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

    Site Public Contact, 724-223-3788, cancer@washingtonhospital.org

    Adam Olson

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa

    Wauwatosa, Wisconsin, 53226

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Shannon Offerman

    Recruiting

  • The Iowa Clinic PC

    West Des Moines, Iowa, 50266

    Site Public Contact, 515-875-9815

    Seema Harichand-Herdt

    Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Eugene K. Lee

    Recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Heath B. Mackley

    Recruiting

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

Other trials in United States

Canada2 sites, 1 recruiting

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

    Site Public Contact, 514-934-1934 ext. 48354, evelyn.ortega@muhc.mcgill.ca

    Fabio L. Cury

    Recruiting

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

    Suspended

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare bladder-intact event-free survival.

SECONDARY OBJECTIVES:

  1. To assess complete response by cystoscopy at 6 months. II. To assess disease-free survival. III. To assess local-regional control. IV. To assess metastasis-free survival. V. To assess overall survival. VI. To assess quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Bladder Cancer Index at 18 months.

VII. To assess Common Terminology Criteria for Adverse Events (CTCAE) adverse events (both acute and late).

EXPLORATORY OBJECTIVES:

  1. To assess fatigue using the Patient Reported Outcomes Measurement Information System Fatigue-4A (PROMIS-Fatigue-4a).

II. To assess quality adjusted survival using European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).

III. To assess cumulative quality of life using EORTC QLC-C30 and Bladder Cancer Index at 24 months.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive one of the following chemotherapy regimens per physicians choice: 1) cisplatin intravenously (IV) once per week for 4 weeks, 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22, and 25, or 3) mitomycin IV on day 1 and 5-fluorouracil IV continuously over 120 hours on days 1-5 and 16-20. Patients receiving cisplatin or gemcitabine continue chemotherapy for 6 weeks if they are receiving radiation according to the standard hypofractionated radiation schedule. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)/magnetic resonance imaging (MRI) and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.

ARM 2: Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years and then annually for 5 years.

Being tested
Biospecimen Collection, Cisplatin, Computed Tomography, Fluorouracil, Gemcitabine
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and urine sample collection

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MitomycinDrug

    Also called Ametycine, Jelmyto, MITO, Mito-C

    Given IV

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

Study groups in NCT06770582
Study groupRoleWhat they receive
Arm 1 (Chemotherapy and radiation)Active comparatorPatients receive one of the following chemotherapy regimens per physicians choice: 1) cisplatin IV once per week for 4 weeks, 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22, and 25, or 3) mitomycin IV on day 1 and 5-fluorouracil IV continuously over 120 hours on days 1-5 and 16-20. Patients receiving cisplatin or gemcitabine continue chemotherapy for 6 weeks if they are receiving radiation according to the standard hypofractionated radiation schedule. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.
Receives: Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine; Procedure: Magnetic Resonance Imaging; Drug: Mitomycin; Other: Questionnaire Administration; Radiation: Radiation Therapy
Arm 2 (Pembrolizumab and radiation)ExperimentalPatients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Other: Questionnaire Administration; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder intact event-free survival (BIEFS)

    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.

    Measured: Up to 5 years

  2. Global quality of life

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

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Complete response by cystoscopy

    The proportion achieving complete response will be compared using the two-sample binomial test. Further analysis may consist of using a binary outcome regression model (i.e., logistic regression) to compute the relative odds of response adjusted for any factors that may appear imbalanced by treatment arm.

    Measured: At 6 months

  2. Disease free survival

    Defined in standard specification as time free of any disease failure (local/regional/distant), or death from any cause. Will be evaluated via the Kaplan-Meier estimator and logrank test.

    Measured: Up to 5 years

  3. Local-regional control

    Will be estimated via the cumulative incidence estimator, treating death as a competing event.

    Measured: Up to 5 years

  4. Metastasis free survival

    Will be evaluated via the Kaplan-Meier estimator and logrank test.

    Measured: Up to 5 years

  5. Overall survival

    Will be estimated via the Kaplan-Meier estimator.

    Measured: Up to 5 years

  6. Quality of life

    Assessed using the Bladder Cancer Index and EORTC-QLQ-C30.

    Measured: Up to 2 years

  7. Incidence of adverse events (AE)

    Assessed using the Common Terminology Criteria for Adverse Events. Counts and frequencies will be reported for the worst grade per AE experienced per patient by treatment arm. Differences in frequency by treatment arm of AE grade, singly or grouped into larger categories (for example, grade 3 or higher vs lower) with be tested using a chi-squared test or Fisher's exact test with a significance level of 0.05.

    Measured: Up to 3 years

  8. Bladder specific quality of life

    Using the Bladder Cancer Index.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start3 Jun 2025
  3. Primary completion1 Feb 2032 (estimated)
  4. Study completion1 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06770582
Sponsor's protocol ID
NCI-2025-00008
Other IDs
NCI-2025-00008, NRG-GU014, NRG-GU014, U10CA180868
Status last verified
Sep 2026
First submitted
9 Jan 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Cisplatin and Computed Tomography in people with Non-Muscle Invasive Bladder Urothelial Carcinoma and Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, run by National Cancer Institute (NCI) at 147 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder intact event-free survival (BIEFS) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06770582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in