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

June 10, 2026 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Fabio L. Cury
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group - Fayetteville
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group - Rogers
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • AIS Cancer Center at San Joaquin Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 661-323-4673
        • Principal Investigator:
          • Luis Mariscal
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Lauren A. Lukas
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Contact:
        • Principal Investigator:
          • Lauren A. Lukas
    • Colorado
      • Edwards, Colorado, United States, 81632
        • Recruiting
        • Shaw Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 970-569-7429
        • Principal Investigator:
          • Erin Schwab
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • UF Health Cancer Institute - Gainesville
        • Contact:
        • Principal Investigator:
          • Daniel V. Araujo
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Bruno R. Bastos
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Kamran Salari
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Kamran Salari
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Kamran Salari
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Kamran Salari
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Proton Therapy Center
        • Contact:
        • Principal Investigator:
          • Kamran Salari
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush MD Anderson Cancer Center
        • Principal Investigator:
          • Dian Wang
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Pella, Iowa, United States, 50219
        • Recruiting
        • UI Healthcare Mission Cancer and Blood - Pella
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic PC
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
          • Site Public Contact
          • Phone Number: 515-875-9815
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital-Indian Creek Campus
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Louisiana Hematology Oncology Associates LLC
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Mary Bird Perkins Cancer Center
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Gonzales, Louisiana, United States, 70737
        • Recruiting
        • Mary Bird Perkins Cancer Center - Gonzales
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70002
        • Recruiting
        • Mary Bird Perkins Cancer Center - Metairie
        • Principal Investigator:
          • Scott E. Delacroix
        • Contact:
          • Site Public Contact
          • Phone Number: 504-584-6990
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
        • Principal Investigator:
          • Sophia C. Kamran
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brighton, Michigan, United States, 48114
      • Canton, Michigan, United States, 48188
      • Chelsea, Michigan, United States, 48118
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Samir Narayan
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Michigan Healthcare Professionals Pontiac
        • Principal Investigator:
          • Samir Narayan
        • Contact:
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Active, not recruiting
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Saint Mary's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Miller-Dwan Hospital
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center - Briarcliff
        • Principal Investigator:
          • Eugene K. Lee
        • Contact:
          • Site Public Contact
          • Phone Number: 913-588-3671
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Justin M. Haseltine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Principal Investigator:
          • Mary E. Westerman
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Active, not recruiting
        • Sanford Broadway Medical Center
      • Fargo, North Dakota, United States, 58122
        • Active, not recruiting
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Michael Siedow
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Siedow
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Doctors Hospital
        • Contact:
        • Principal Investigator:
          • Michael Siedow
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Dublin Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Michael Siedow
      • Mansfield, Ohio, United States, 44903
        • Recruiting
        • OhioHealth Mansfield Hospital
        • Contact:
        • Principal Investigator:
          • Michael Siedow
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Contact:
        • Principal Investigator:
          • Michael Siedow
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Tyler Gunter
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Heath B. Mackley
        • Contact:
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Adam Olson
        • Contact:
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Adam Olson
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Hyma Polimera
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Adam Olson
        • Contact:
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Cancer Center - Monroeville
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • New Castle, Pennsylvania, United States, 16105
        • Recruiting
        • UPMC Hillman Cancer Center - New Castle
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Magee Womens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Principal Investigator:
          • Adam Olson
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
      • Seneca, Pennsylvania, United States, 16346
        • Recruiting
        • UPMC Cancer Center at UPMC Northwest
        • Contact:
          • Site Public Contact
          • Phone Number: 814-676-7900
        • Principal Investigator:
          • Adam Olson
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Cancer Center-Washington
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Washington Hospital Radiation Oncology
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
        • Principal Investigator:
          • Alexander P. Lukez
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Alexander P. Lukez
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Alexander P. Lukez
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Alfredo I. Urdaneta
        • Contact:
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Contact:
        • Principal Investigator:
          • Alfredo I. Urdaneta
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Joanna A. Kolodney
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Northwest Wisconsin Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 (Chemotherapy and radiation)
Patients 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Gemcitabine
Given IV
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Energy Type
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Procedure: Biospecimen Collection
Undergo blood and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Drug: Mitomycin
Given IV
Other Names:
  • Mutamycin
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycine
  • NCI-C04706
  • Mitomycin pyelocalyceal
Experimental: Arm 2 (Pembrolizumab and radiation)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Energy Type
Procedure: Biospecimen Collection
Undergo blood and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder intact event-free survival (BIEFS)
Time Frame: 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.
Up to 5 years
Global quality of life
Time Frame: Up 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.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response by cystoscopy
Time Frame: At 6 months
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.
At 6 months
Disease free survival
Time Frame: Up to 5 years
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.
Up to 5 years
Local-regional control
Time Frame: Up to 5 years
Will be estimated via the cumulative incidence estimator, treating death as a competing event.
Up to 5 years
Metastasis free survival
Time Frame: Up to 5 years
Will be evaluated via the Kaplan-Meier estimator and logrank test.
Up to 5 years
Overall survival
Time Frame: Up to 5 years
Will be estimated via the Kaplan-Meier estimator.
Up to 5 years
Incidence of adverse events (AE)
Time Frame: Up to 3 years
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.
Up to 3 years
Bladder specific quality of life
Time Frame: Up to 2 years
Using the Bladder Cancer Index.
Up to 2 years
Quality of life
Time Frame: Up to 2 years
Assessed using the Bladder Cancer Index and EORTC-QLQ-C30.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Up to 2 years
Using Patient Reported Outcomes Measurement Information System Fatigue-4A. Calculated by summing all 4 questions (all 4 questions are required to be completed to score the tool). Raw scores range from 4 to 20 and are standardized to a T score following the scoring instructions.
Up to 2 years
Quality adjusted survival
Time Frame: Up to 2 years
Index scores from the European Quality of Life Five Dimension Five Level Scale will be calculated at each time point and change from baseline to post-treatment scores compared between treatment arms using a t-test with a 2-sided significance level of 0.05. If there are significant differences, then a quality-adjusted life year (QALY) analysis will be conducted. QALYs are defined by the weighted sum of different time episodes added up to a total quality-adjusted survival time. The difference in QALYs between arms will be reported along with the 95% confidence interval.
Up to 2 years
Cumulative global quality of life
Time Frame: Up to 2 years
Using the EORTC-QLQ-C30 and Bladder Cancer Index.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brian C Baumann, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2032

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2025-00008 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NRG-GU014 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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