Muscle Invasive Bladder Urothelial CarcinomaPhase 2NCT07061964
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Cystoscopy in people with Muscle Invasive Bladder Urothelial Carcinoma and Stage II Bladder Cancer AJCC v8, run by National Cancer Institute (NCI) at 181 sites in United States.
Trial summary
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Cystoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 181 sitesUnited States
- Study dates
- 25 Nov 2025to 31 Jul 2027
- 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
- Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
- Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
- Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed
- NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT
- Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
- Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement
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- NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)
- Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
- Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology
- Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy
- NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (> 50%) of the tumor is urothelial cell carcinoma
- Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)
- Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine [GC] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
- Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC
- NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed
- Participants must not have had prior pelvic radiotherapy
- Participants must not have received a live attenuated vaccination within 28 days prior to registration
- Participants with conditions requiring immunosuppressive doses of steroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration
- Participants must be ≥ 18 years old at the time of registration
- Participants must have Zubrod performance status of 0-2
- Participants must have a complete medical history and physical exam within 28 days prior to registration
- Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration)
- Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration)
- Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration)
- Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)
- Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)
- Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
- Participants 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. To be eligible for this trial, patients should be class II or better
- Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- Participants must be offered the opportunity to participate in specimen banking
- Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations
Who cannot join
None listed.
Trial locations and contacts
181 sites in 1 country. Contact the study team or a site near you to ask about taking part.
181 sites in 1 country
United States181 sites, 171 recruiting
- 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
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Francis J. Cuevas
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Tyler Robin
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Priyank P. Patel
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Leslie Ballas
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Charles C. Peyton
- Recruiting
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Brett Diamond
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Kent W. Mouw
- Recruiting
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Francis J. Cuevas
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Joseph M. Caster
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, protocols@swog.org
John M. Schallenkamp
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Sean Sachdev
- Recruiting
Northwestern Medicine Cancer Center Old Irving Park
Chicago, Illinois, 60641
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Sean Sachdev
- Recruiting
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Francis J. Cuevas
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Bailey A. Nelson
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Site Public Contact, 216-778-7559, ababal@metrohealth.org
Roger Ove
- 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
- Suspended
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Shang-Jui Wang
- Recruiting
City of Hope Corona
Corona, California, 92882
Site Public Contact, 626-256-4673, becomingapatient@coh.org
Abhishek Tripathi
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Suzanne M. Cole
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- 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
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Sean Sachdev
- Recruiting
UCHealth - Cherry Creek
Denver, Colorado, 80206
Site Public Contact, protocols@swog.org
Tyler Robin
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- 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
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
- Suspended
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Abhishek Tripathi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- 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
Priyank P. Patel
- Suspended
Crossroads Cancer Center
Effingham, Illinois, 62401
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
Site Public Contact, 479-872-8100, research@hogonc.com
Joseph T. Beck
- Recruiting
Hunterdon Medical Center
Flemington, New Jersey, 08822
Site Public Contact, 908-237-2330
Myron E. Bednar
- Recruiting
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Leen Khoury
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Tyler Robin
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, protocols@swog.org
Tyler Robin
- Suspended
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
Franklin, Wisconsin, 53132
Site Public Contact, AWRI.Inquiry@Ascension.org
Francis J. Cuevas
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Sean Sachdev
- Recruiting
The West Clinic - Wolf River
Germantown, Tennessee, 38138
Site Public Contact, 901-683-0055, afletcher@westclinic.com
Daniel A. Vaena
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Public Contact, 602-747-9738
Chinedu Mmeje
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Sean Sachdev
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Sean Sachdev
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, protocols@swog.org
Tyler Robin
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Site Public Contact, 720-848-0650
Tyler Robin
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Daniel A. Hamstra
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Site Public Contact, 877-467-3411
Abhishek Tripathi
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
John C. Henegan
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Mark D. Tyson
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
Jersey City Medical Center
Jersey City, New Jersey, 07302
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Lara Hathout
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Sean Sachdev
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Abhishek Tripathi
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
James B. Yu
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Insija Ilyas Selene
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Site Public Contact, 973-322-5200
Lara Hathout
- Recruiting
UCHealth Lone Tree Health Center
Lone Tree, Colorado, 80124
Site Public Contact, protocols@swog.org
Tyler Robin
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Lara Hathout
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Siamak Daneshmand
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Siamak Daneshmand
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Leslie Ballas
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Scott R. Silva
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu
Scott R. Silva
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Tyler Robin
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
Mequon, Wisconsin, 53097
Site Public Contact, AWRI.Inquiry@Ascension.org
Francis J. Cuevas
- Recruiting
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
Milwaukee, Wisconsin, 53211
Site Public Contact, AWRI.Inquiry@Ascension.org
Francis J. Cuevas
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Community Medical Center
Missoula, Montana, 59804
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Muhammad Mohsin Fareed
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Lara Hathout
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Rajasree P. Chowdry
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Kyle Rose
- Recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Site Public Contact, 212-746-1848
Rohit Jain
- Recruiting
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265
Site Public Contact, 770-400-6629
Bamidele A. Adesunloye
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Sean Sachdev
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Kelly L. Stratton
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Sean Sachdev
- Recruiting
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, AWRI.inquiry@ascension.org
Francis J. Cuevas
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Muhammad Mohsin Fareed
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Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Ronac Mamtani
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Joseph M. Caster
- Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Site Public Contact, 855-776-0015
Mark D. Tyson
- Suspended
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Ascension All Saints Hospital-Spring Street-Racine
Racine, Wisconsin, 53405
Site Public Contact, AWRI.Inquiry@Ascension.org
Francis J. Cuevas
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
Suzanne M. Cole
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Alfredo I. Urdaneta
- 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
Moffitt Cancer Center at SouthShore
Ruskin, Florida, 33570
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
George D. Grass
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Mamta Parikh
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
James B. Yu
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Bogdana Schmidt
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu
Chul S. Ha
- Suspended
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Omar Y. Mian
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Omar Y. Mian
- Recruiting
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Joseph M. Caster
- Recruiting
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Abhishek Tripathi
- 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
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Judy Huang
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
George D. Grass
- Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
George D. Grass
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
George D. Grass
- Recruiting
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356
Site Public Contact, 818-981-3818
Leslie Ballas
- Recruiting
Scott and White Memorial Hospital
Temple, Texas, 76508
Site Public Contact, 254-724-5407
Lucas Wong
- Recruiting
Community Medical Center
Toms River, New Jersey, 08755
Site Public Contact, 732-557-8294, Lennette.Gonzales@rwjbh.org
Lara Hathout
- Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
City of Hope Upland
Upland, California, 91786
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Abhishek Tripathi
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Sean Sachdev
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- 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
Francis J. Cuevas
- Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
George D. Grass
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Bailey A. Nelson
- Recruiting
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Site Public Contact, 515-875-9815
Seema Harichand-Herdt
- Recruiting
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Daniel P. Petrylak
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Joseph M. Caster
- Recruiting
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Site Public Contact, 508-856-3216, cancer.research@umassmed.edu
Kriti Mittal
About this study
Official title: Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate whether 3-year bladder intact event-free survival (BI-EFS) is at least 70% in participants with clinically T0-clinically T1 without multifocal carcinoma in situ (CIS) following neoadjuvant therapy (NAT) for muscle-invasive bladder cancer (MIBC) who receive radiotherapy (RT) + pembrolizumab (MK-3475).
SECONDARY OBJECTIVES:
- To estimate BI-EFS in participants who receive RT + pembrolizumab (MK-3475). II. To estimate local muscle invasive recurrence-free survival in participants who receive RT+ pembrolizumab (MK-3475).
III. To estimate the metastasis-free survival (MFS) in participants who receive RT+ pembrolizumab (MK-3475).
IV. To estimate the overall survival (OS) in participants who receive RT + pembrolizumab (MK-3475).
- To estimate the rate of salvage cystectomy in participants who receive RT+ pembrolizumab (MK-3475).
VI. To evaluate the frequency and severity of toxicities in participants who receive RT + pembrolizumab (MK-3475).
PATIENT REPORTED OUTCOMES (PRO)-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) OBJECTIVE:
- To evaluate participant-reported symptoms using selected items from Gastrointestinal, Genitourinary and sexual function domains of the PRO-CTCAE, with the goal of characterizing the frequency, severity, and interference of treatment-related symptoms.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Patients undergo photon beam RT once daily (QD) on Monday-Friday for up to 20 treatments and receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo transurethral resection of bladder tumor (TURBT) with tissue sample collection at pre-registration and computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET), cystoscopy, and urine and blood sample collection throughout the study.
After completion of study treatment, patients are followed every 26 weeks until year 2 and then every 52 weeks up to year 5.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Cystoscopy, Magnetic Resonance Imaging, Pembrolizumab
- 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 tissue, urine, and blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CystoscopyProcedure or surgery
Also called CS
Undergo cystoscopy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given IV
Photon Beam Radiation TherapyRadiation
Also called External beam radiation therapy using photons (procedure), Photon, Photon EBRT, Photon External Beam Radiotherapy
Undergo photon beam RT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET
Questionnaire AdministrationOther
Ancillary studies
Transurethral Resection of Bladder TumorProcedure or surgery
Also called Transurethral resection (TURBT), TURBT
Undergo TURBT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (photon beam RT, pembrolizumab) | Experimental | Patients undergo photon beam RT QD on Monday-Friday for up to 20 treatments and receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo TURBT with tissue sample collection at pre-registration and CT, MRI or PET, cystoscopy, and urine and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Cystoscopy; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Radiation: Photon Beam Radiation Therapy; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Transurethral Resection of Bladder Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder intact event-free survival (BI-EFS)
Will be evaluated as the percentage of participants who do not experience a BI-EFS event using a Kaplan-Meier estimate. A single-arm test of proportions will be used to test against the null hypothesis (true BI-EFS = 55%). Standard errors will be calculated using Greenwood's formula. If the upper bound of the one-sided 90% confidence interval includes 70%, then the radiation therapy + pembrolizumab regimen will be concluded to be active in this population.
Measured: Within 3 years after registration
Secondary outcomes (6)
BI-EFS
Measured: From registration to the first documentation of a BI-EFS event, assessed up to 5 years
Local muscle invasive recurrence-free survival
Measured: From date of registration to first radiologic or histologic evidence of local muscle invasive bladder carcinoma recurrence, assessed up to 5 years
Metastasis-free survival
Measured: From date of registration to first radiologic or histologic evidence of metastatic disease or death due to any cause, assessed up to 5 years
Overall survival
Measured: From date of registration to date of death due to any cause, assessed up to 5 years
Salvage cystectomy
Will be defined as the number of participants that undergo a radical cystectomy.
Measured: Up to 5 years
Incidence of adverse events
Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 30 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start25 Nov 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leslie Ballas, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061964
- Sponsor's protocol ID
- NCI-2025-04663
- Other IDs
- NCI-2025-04663, S2427, S2427, U10CA180888
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2025
- Last updated
- 1 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)
- ClinicalTrials.gov ID
- NCT07061964
- Acronym / sponsor ID
- NCI-2025-04663
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate whether 3-year bladder intact event-free survival (BI-EFS) is at least 70% in participants with clinically T0-clinically T1 without multifocal carcinoma in situ (CIS) following neoadjuvant therapy (NAT) for muscle-invasive bladder cancer (MIBC) who receive radiotherapy (RT) + pembrolizumab (MK-3475).
SECONDARY OBJECTIVES:
- To estimate BI-EFS in participants who receive RT + pembrolizumab (MK-3475). II. To estimate local muscle invasive recurrence-free survival in participants who receive RT+ pembrolizumab (MK-3475).
III. To estimate the metastasis-free survival (MFS) in participants who receive RT+ pembrolizumab (MK-3475).
IV. To estimate the overall survival (OS) in participants who receive RT + pembrolizumab (MK-3475).
- To estimate the rate of salvage cystectomy in participants who receive RT+ pembrolizumab (MK-3475).
VI. To evaluate the frequency and severity of toxicities in participants who receive RT + pembrolizumab (MK-3475).
PATIENT REPORTED OUTCOMES (PRO)-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) OBJECTIVE:
- To evaluate participant-reported symptoms using selected items from Gastrointestinal, Genitourinary and sexual function domains of the PRO-CTCAE, with the goal of characterizing the frequency, severity, and interference of treatment-related symptoms.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Patients undergo photon beam RT once daily (QD) on Monday-Friday for up to 20 treatments and receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo transurethral resection of bladder tumor (TURBT) with tissue sample collection at pre-registration and computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET), cystoscopy, and urine and blood sample collection throughout the study.
After completion of study treatment, patients are followed every 26 weeks until year 2 and then every 52 weeks up to year 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (photon beam RT, pembrolizumab) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Cystoscopy, Procedure: Magnetic Resonance Imaging, Biological: Pembrolizumab, Radiation: Photon Beam Radiation Therapy, Procedure: Positron Emission Tomography, Other: Questionnaire Administration, Procedure: Transurethral Resection of Bladder TumorPatients undergo photon beam RT QD on Monday-Friday for up to 20 treatments and receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo TURBT with tissue sample collection at pre-registration and CT, MRI or PET, cystoscopy, and urine and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
- Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
- Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed
- Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
- Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo tissue, urine, and blood sample collection | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
| CystoscopyAlso: CSUndergo cystoscopy | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
| PembrolizumabAlso: BCD-201, GME 751, GME751, KeytrudaGiven IV | Biological | Treatment (photon beam RT, pembrolizumab) |
| Photon Beam Radiation TherapyAlso: External beam radiation therapy using photons (procedure), Photon, Photon EBRT, Photon External Beam RadiotherapyUndergo photon beam RT | Radiation | Treatment (photon beam RT, pembrolizumab) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (photon beam RT, pembrolizumab) |
| Transurethral Resection of Bladder TumorAlso: Transurethral resection (TURBT), TURBTUndergo TURBT | Procedure or surgery | Treatment (photon beam RT, pembrolizumab) |
Primary outcome
Bladder intact event-free survival (BI-EFS)
Time frame: Within 3 years after registration
Will be evaluated as the percentage of participants who do not experience a BI-EFS event using a Kaplan-Meier estimate. A single-arm test of proportions will be used to test against the null hypothesis (true BI-EFS = 55%). Standard errors will be calculated using Greenwood's formula. If the upper bound of the one-sided 90% confidence interval includes 70%, then the radiation therapy + pembrolizumab regimen will be concluded to be active in this population.
6 secondary outcomes
BI-EFS
Time frame: From registration to the first documentation of a BI-EFS event, assessed up to 5 years
Local muscle invasive recurrence-free survival
Time frame: From date of registration to first radiologic or histologic evidence of local muscle invasive bladder carcinoma recurrence, assessed up to 5 years
Metastasis-free survival
Time frame: From date of registration to first radiologic or histologic evidence of metastatic disease or death due to any cause, assessed up to 5 years
Overall survival
Time frame: From date of registration to date of death due to any cause, assessed up to 5 years
Salvage cystectomy
Time frame: Up to 5 years
Incidence of adverse events
Time frame: Up to 30 days after last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: 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.
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Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leslie Ballas principal investigator
SWOG Cancer Research Network
181 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Cystoscopy in people with Muscle Invasive Bladder Urothelial Carcinoma and Stage II Bladder Cancer AJCC v8, run by National Cancer Institute (NCI) at 181 sites in United States.
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 39 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 1 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 181 sites in United States. 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 (BI-EFS) (time frame: Within 3 years after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.