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RECRUITING Phase 2 ClinicalTrials.gov

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT07061964

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo tissue, urine, and blood sample collection
  • Computed Tomography (Procedure)
    Undergo CT
  • Cystoscopy (Procedure)
    Undergo cystoscopy
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Pembrolizumab (Biological)
    Given IV
  • Photon Beam Radiation Therapy (Radiation)
    Undergo photon beam RT
  • Positron Emission Tomography (Procedure)
    Undergo PET
  • Questionnaire Administration (Other)
    Ancillary studies
  • Transurethral Resection of Bladder Tumor (Procedure)
    Undergo TURBT

Eligibility criteria

Inclusion Criteria: * 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 * 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

Conditions

Muscle Invasive Bladder Urothelial Carcinoma Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
  • Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
  • Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas, United States
  • Highlands Oncology Group - Rogers — Rogers, Arkansas, United States
  • Highlands Oncology Group — Springdale, Arkansas, United States
  • Tower Cancer Research Foundation — Beverly Hills, California, United States
  • City of Hope Corona — Corona, California, United States
  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • City of Hope at Irvine Lennar — Irvine, California, United States
  • City of Hope Antelope Valley — Lancaster, California, United States
  • Los Angeles General Medical Center — Los Angeles, California, United States
  • USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
  • City of Hope South Pasadena — South Pasadena, California, United States
  • Cedars-Sinai Cancer - Tarzana — Tarzana, California, United States
  • City of Hope Upland — Upland, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • UCHealth - Cherry Creek — Denver, Colorado, United States
  • Shaw Cancer Center — Edwards, Colorado, United States
  • Poudre Valley Hospital — Fort Collins, Colorado, United States
  • Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
  • UCHealth Greeley Hospital — Greeley, Colorado, United States
  • UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
  • UCHealth Lone Tree Health Center — Lone Tree, Colorado, United States
  • Medical Center of the Rockies — Loveland, Colorado, United States
  • Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
  • Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States
  • Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
  • Mayo Clinic in Florida — Jacksonville, Florida, United States
  • Moffitt Cancer Center at SouthShore — Ruskin, Florida, United States
  • Moffitt Cancer Center-International Plaza — Tampa, Florida, United States
  • Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States
  • CTCA at Southeastern Regional Medical Center — Newnan, Georgia, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • Rush-Copley Medical Center — Aurora, Illinois, United States
  • OSF Saint Joseph Medical Center — Bloomington, Illinois, United States
  • Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
  • Illinois CancerCare-Canton — Canton, Illinois, United States
  • Illinois CancerCare-Carthage — Carthage, Illinois, United States
  • Northwestern University — Chicago, Illinois, United States
  • Northwestern Medicine Cancer Center Old Irving Park — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
  • Illinois CancerCare-Dixon — Dixon, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Crossroads Cancer Center — Effingham, Illinois, United States
  • Illinois CancerCare-Eureka — Eureka, Illinois, United States
  • NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
  • Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
  • NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States
  • Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States
  • Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States
  • NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois, United States
  • Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
  • Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
  • Illinois CancerCare-Macomb — Macomb, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States
  • Northwestern Medicine Orland Park — Orland Park, Illinois, United States
  • Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
  • Illinois CancerCare-Pekin — Pekin, Illinois, United States
  • Illinois CancerCare-Peoria — Peoria, Illinois, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center — Peoria, Illinois, United States
  • OSF Saint Francis Medical Center — Peoria, Illinois, United States
  • Illinois CancerCare-Peru — Peru, Illinois, United States
  • Illinois CancerCare-Princeton — Princeton, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Springfield Memorial Hospital — Springfield, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
  • Illinois CancerCare - Washington — Washington, Illinois, United States
  • Mary Greeley Medical Center — Ames, Iowa, United States
  • McFarland Clinic - Ames — Ames, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • McFarland Clinic - Boone — Boone, Iowa, United States
  • Mercy Cancer Center-West Lakes — Clive, Iowa, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
  • McFarland Clinic - Jefferson — Jefferson, Iowa, United States
  • McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • The Iowa Clinic PC — West Des Moines, Iowa, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • University Medical Center New Orleans — New Orleans, Louisiana, United States
  • Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • UMass Memorial Medical Center - University Campus — Worcester, Massachusetts, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Fairview Southdale Hospital — Edina, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Saint Francis Medical Center — Cape Girardeau, Missouri, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Jefferson Cherry Hill Hospital — Cherry Hill, New Jersey, United States
  • Hunterdon Medical Center — Flemington, New Jersey, United States
  • Jersey City Medical Center — Jersey City, New Jersey, United States
  • Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
  • Monmouth Medical Center — Long Branch, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Sidney Kimmel Cancer Center Washington Township — Sewell, New Jersey, United States
  • Community Medical Center — Toms River, New Jersey, United States
  • The New York Hospital Medical Center of Queens — Flushing, New York, United States
  • NYP/Weill Cornell Medical Center — New York, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
  • MetroHealth Medical Center — Cleveland, Ohio, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Smilow Cancer Hospital Care Center - Westerly — Westerly, Rhode Island, United States
  • Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • The West Clinic - Wolf River — Germantown, Tennessee, United States
  • Parkland Memorial Hospital — Dallas, Texas, United States
  • UT Southwestern Simmons Cancer Center - RedBird — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
  • UT Southwestern Clinical Center at Richardson/Plano — Richardson, Texas, United States
  • University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
  • Scott and White Memorial Hospital — Temple, Texas, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • Dartmouth Cancer Center - North — Saint Johnsbury, Vermont, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • University of Washington Medical Center - Montlake — Seattle, Washington, United States
  • West Virginia University Healthcare — Morgantown, West Virginia, United States
  • Camden Clark Medical Center — Parkersburg, West Virginia, United States
  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton — Appleton, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield — Brookfield, Wisconsin, United States
  • Ascension Calumet Hospital-Chilton — Chilton, Wisconsin, United States
  • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson — Franklin, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon — Mequon, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus — Milwaukee, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Oconto Falls — Oconto Falls, Wisconsin, United States
  • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh — Oshkosh, Wisconsin, United States
  • Ascension All Saints Hospital-Spring Street-Racine — Racine, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Sheboygan — Sheboygan, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Sturgeon Bay — Sturgeon Bay, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa — Wauwatosa, Wisconsin, United States
  • Memorial Hospital of Laramie County — Cheyenne, Wyoming, United States
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Official Source

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

View Official Record