Actively Recruiting
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
111
Participants Needed
140
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed muscle invasive urothelial carcinoma of the bladder (cT2-T4aN0M0) within 180 days before starting chemotherapy
- Imaging (CT, MRI, or PET) within 60 days before starting chemotherapy confirming disease stage
- Underwent transurethral resection of bladder tumor (TURBT) with biopsies showing clinically T0-T1 disease within 60 days after last chemotherapy dose
- At least 4 out of 5 systematic biopsies performed during TURBT
- Imaging (CT or MRI preferably with contrast or PET-CT) of chest, abdomen, and pelvis within 60 days after last chemotherapy dose
- Participants with enlarged lymph nodes on imaging must have PET-CT within 70 days before registration and negative biopsy if PET is positive
- No evidence of advanced disease (≥ T2, N1-3, or M1) after chemotherapy
- No small cell, neuroendocrine carcinoma, or plasmacytoid variants on pathology
- No urothelial carcinoma or variant outside the bladder within 24 months prior except specific low-grade upper urinary tract cases
- Allowed to continue PD-1/L1 inhibitor therapy received prior to registration
- Received 3 to 6 cycles of FDA-approved neoadjuvant chemotherapy regimens including cisplatin-based or enfortumab vedotin with PD-1/L1 inhibitors
- No prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies or drugs targeting nectin-4 except for neoadjuvant treatment
- No prior pelvic radiotherapy
- No live attenuated vaccine within 28 days before registration
- Not taking immunosuppressive doses of steroids (>10 mg/day prednisone or equivalent) at registration
- Zubrod performance status 0-2
- Complete medical history and physical exam within 28 days prior to registration
- Adequate blood counts and liver function within 28 days prior
- Creatinine clearance ≥ 40 mL/min or creatinine ≤ institutional upper limit
- Cardiac function class II or better if history of cardiac disease
- HIV positive participants must be on effective therapy with undetectable viral load
- Hepatitis B and C infections properly controlled or cured
- No prior or concurrent malignancy interfering with safety or efficacy assessment
- Not pregnant or nursing and agree to effective contraception if of reproductive potential
- Willing to participate in specimen banking and patient-reported outcome studies if able
- Informed consent provided according to regulations
You will not qualify if you...
- Evidence of disease stage ≥ T2, N1-3, or M1 after neoadjuvant therapy
- Presence of small cell, neuroendocrine carcinoma, or plasmacytoid variants on pathology
- Urothelial carcinoma or variant outside the bladder within 24 months prior except specific low-grade upper urinary tract cases
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies or drugs targeting nectin-4 outside neoadjuvant treatment
- Prior pelvic radiotherapy
- Received live attenuated vaccine within 28 days prior to registration
- Taking immunosuppressive doses of steroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs at registration
- Inadequate blood counts or liver function tests
- Creatinine clearance below 40 mL/min or creatinine above institutional upper limit
- Cardiac function worse than class II for those with cardiac disease history
- Active HIV infection without effective therapy or detectable viral load
- Active hepatitis B or C infection not controlled or cured
- Prior or concurrent malignancy that may interfere with study
- Pregnant or nursing individuals
- Unable or unwilling to provide informed consent according to institutional and federal guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 140 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
5
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States, 72758
Actively Recruiting
6
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
7
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
Actively Recruiting
8
City of Hope Corona
Corona, California, United States, 92882
Actively Recruiting
9
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
10
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
11
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
12
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Suspended
13
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Suspended
14
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
15
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
16
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
17
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States, 91356
Actively Recruiting
18
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
19
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
20
UCHealth - Cherry Creek
Denver, Colorado, United States, 80206
Actively Recruiting
21
Shaw Cancer Center
Edwards, Colorado, United States, 81632
Actively Recruiting
22
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Actively Recruiting
23
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States, 80528
Actively Recruiting
24
UCHealth Greeley Hospital
Greeley, Colorado, United States, 80631
Actively Recruiting
25
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Actively Recruiting
26
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States, 80124
Actively Recruiting
27
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
28
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
29
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States, 33570
Actively Recruiting
30
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States, 33607
Actively Recruiting
31
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Actively Recruiting
32
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
33
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
34
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
Actively Recruiting
35
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Suspended
36
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Suspended
37
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Suspended
38
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
39
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Actively Recruiting
40
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
41
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
42
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Actively Recruiting
43
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
44
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
45
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
46
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
47
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
48
Illinois CancerCare-Dixon
Dixon, Illinois, United States, 61021
Suspended
49
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
50
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Suspended
51
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
52
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
53
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Actively Recruiting
54
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
55
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
56
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
57
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
58
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Actively Recruiting
59
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Actively Recruiting
60
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
61
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Actively Recruiting
62
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
63
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
64
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269
Actively Recruiting
65
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Actively Recruiting
66
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
67
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
68
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
69
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
70
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Actively Recruiting
71
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
72
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
73
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Actively Recruiting
74
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
75
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
76
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
77
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
78
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
79
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
80
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
81
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
82
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
83
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
84
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Actively Recruiting
85
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
86
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
87
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
88
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
89
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
90
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Suspended
91
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
92
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Suspended
93
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
94
The Iowa Clinic PC
West Des Moines, Iowa, United States, 50266
Actively Recruiting
95
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
96
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
97
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
98
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
99
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
100
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
101
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
102
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
103
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
104
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
105
Community Medical Center
Missoula, Montana, United States, 59804
Suspended
106
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
107
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Actively Recruiting
108
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
109
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
110
The New York Hospital Medical Center of Queens
Flushing, New York, United States, 11355
Suspended
111
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
112
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
113
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
114
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
115
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
116
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
117
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
118
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
119
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
120
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
121
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
122
The West Clinic - Wolf River
Germantown, Tennessee, United States, 38138
Actively Recruiting
123
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
124
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, United States, 75237
Actively Recruiting
125
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
126
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
127
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
128
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States, 75080
Actively Recruiting
129
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
130
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
Actively Recruiting
131
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
132
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
133
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
134
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
135
Camden Clark Medical Center
Parkersburg, West Virginia, United States, 26101
Actively Recruiting
136
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
137
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
138
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Actively Recruiting
139
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
140
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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