Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Start Date
11/25/2025
Completion Date
7/31/2027
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.
Detailed Description
PRIMARY OBJECTIVE: I. 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: I. 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). V. 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: I. 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: I. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Computed Tomography
Cystoscopy
Magnetic Resonance Imaging
Pembrolizumab
Photon Beam Radiation Therapy
Positron Emission Tomography
Questionnaire Administration
Transurethral Resection of Bladder Tumor
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas 72703
United States
Highlands Oncology Group - Rogers
Rogers, Arkansas 72758
United States
Highlands Oncology Group
Springdale, Arkansas 72762
United States
Tower Cancer Research Foundation
Beverly Hills, California 90211
United States
City of Hope Corona
Corona, California 92882
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States
City of Hope Antelope Valley
Lancaster, California 93534
United States
Los Angeles General Medical Center
Los Angeles, California 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
City of Hope South Pasadena
South Pasadena, California 91030
United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California 91356
United States
City of Hope Upland
Upland, California 91786
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
UCHealth - Cherry Creek
Denver, Colorado 80206
United States
Shaw Cancer Center
Edwards, Colorado 81632
United States
Poudre Valley Hospital
Fort Collins, Colorado 80524
United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
United States
UCHealth Greeley Hospital
Greeley, Colorado 80631
United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado 80124
United States
Medical Center of the Rockies
Loveland, Colorado 80538
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Moffitt Cancer Center at SouthShore
Ruskin, Florida 33570
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia 30265
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Rush-Copley Medical Center
Aurora, Illinois 60504
United States
OSF Saint Joseph Medical Center
Bloomington, Illinois 61701
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Northwestern University
Chicago, Illinois 60611
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Illinois CancerCare-Dixon
Dixon, Illinois 61021
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Crossroads Cancer Center
Effingham, Illinois 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
United States
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United States
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Springfield Memorial Hospital
Springfield, Illinois 62781
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Illinois CancerCare - Washington
Washington, Illinois 61571
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic - Ames
Ames, Iowa 50010
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United States
McFarland Clinic - Boone
Boone, Iowa 50036
United States
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
United States
The Iowa Clinic PC
West Des Moines, Iowa 50266
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Fairview Southdale Hospital
Edina, Minnesota 55435
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Community Medical Center
Missoula, Montana 59804
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey 08002
United States
Hunterdon Medical Center
Flemington, New Jersey 08822
United States
Jersey City Medical Center
Jersey City, New Jersey 07302
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
United States
The New York Hospital Medical Center of Queens
Flushing, New York 11355
United States
NYP/Weill Cornell Medical Center
New York, New York 10065
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
MetroHealth Medical Center
Cleveland, Ohio 44109
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
The West Clinic - Wolf River
Germantown, Tennessee 38138
United States
Parkland Memorial Hospital
Dallas, Texas 75235
United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Scott and White Memorial Hospital
Temple, Texas 76508
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Swedish Medical Center-First Hill
Seattle, Washington 98122
United States
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
Camden Clark Medical Center
Parkersburg, West Virginia 26101
United States
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin 54915
United States
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin 53045
United States
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin 53014
United States
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
Franklin, Wisconsin 53132
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
United States
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
Mequon, Wisconsin 53097
United States
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
Milwaukee, Wisconsin 53211
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
United States
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
Oshkosh, Wisconsin 54904
United States
Ascension All Saints Hospital-Spring Street-Racine
Racine, Wisconsin 53405
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
United States
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
Wauwatosa, Wisconsin 53226
United States