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RECRUITING

NCT07061964

PHASE2

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)

View on ClinicalTrials.gov

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. 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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2025-11-25

Completion Date

2027-07-31

Last Updated

2026-04-09

Healthy Volunteers

Conditions

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo tissue, urine, and blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Cystoscopy

Undergo cystoscopy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

RADIATION

Photon Beam Radiation Therapy

Undergo photon beam RT

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo TURBT

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

Locations (128)

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

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

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

Medical Center of the Rockies

Loveland, Colorado, 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

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

Tufts Medical Center

Boston, Massachusetts, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Community Medical Center

Missoula, Montana, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Hunterdon Medical Center

Flemington, 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

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

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 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

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

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

West Virginia University Healthcare

Morgantown, West Virginia, United States

Camden Clark Medical Center

Parkersburg, West Virginia, 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

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (128)