Actively Recruiting
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
160
Participants Needed
128
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.
CONDITIONS
Official Title
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without lymph node or metastatic disease
- High-grade T1 disease meeting at least one: recurrence after TURBT and intravesical therapy, or T1 with high-risk pathologic features, or persistent T1 after repeat TURBT
- Restaging TURBT performed with uninvolved muscularis propria if absent in initial TURBT
- All visible papillary tumors removed before restaging
- No pure squamous cell carcinoma or adenocarcinoma
- No neuroendocrine features
- No diffuse carcinoma in situ
- No prostatic urethral involvement
- Age 18 or older
- ECOG performance status 0-2
- Negative pregnancy test if of childbearing potential within 14 days before registration
- Adequate blood counts: ANC ≥ 1500 cells/mm³, platelets ≥ 100,000 cells/mm³, hemoglobin ≥ 9 g/dl
- Adequate kidney and liver function
- All recent therapy side effects resolved to less than grade 3 or baseline
- No history of pelvic radiation
- No prior systemic chemotherapy or immunotherapy for urothelial carcinoma
- No prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody or similar therapies
- No live vaccine within 30 days before registration
- Recovered from acute cardiac illness and NYHA classification II or better
- No active infection requiring IV antibiotics
- No active autoimmune disease requiring systemic treatment in past 2 years
- No history of certain lung conditions or pneumonitis requiring steroids
- No history of bone marrow or solid organ transplant
- No active tuberculosis
- No hydronephrosis
- No upper tract urothelial carcinoma within 24 months
- No untreated prostate cancer
- Prior or concurrent malignancy allowed if not interfering with study
- No glucocorticoids except physiologic doses
- No allergy to study drug components
You will not qualify if you...
- Presence of nodal disease ≥ 1 cm or suspicious PET-avid lymph nodes
- Pure squamous cell carcinoma or adenocarcinoma of the bladder
- Neuroendocrine features (small or large cell)
- Diffuse carcinoma in situ
- Prostatic urethral involvement
- ECOG performance status greater than 2
- Positive pregnancy test if of childbearing potential
- Unresolved grade 3 or higher adverse events from prior therapy
- History of pelvic radiation therapy
- Prior systemic chemotherapy or immunotherapy for urothelial carcinoma
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies or similar agents
- Live vaccine administered within 30 days before registration
- Active infection requiring IV antibiotics
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis requiring steroids
- History of allogeneic bone marrow or solid organ transplant
- Active tuberculosis
- Evidence of hydronephrosis
- Upper tract urothelial carcinoma within 24 months
- Untreated prostate cancer
- Use of glucocorticoids above physiologic doses except as allowed
- Allergic reaction to drug excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 128 locations
1
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States, 72758
Actively Recruiting
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
4
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States, 93301
Actively Recruiting
5
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Suspended
6
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Suspended
7
Shaw Cancer Center
Edwards, Colorado, United States, 81632
Actively Recruiting
8
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
9
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
10
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
11
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
12
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
13
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
14
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
15
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
16
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
17
Rush MD Anderson Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
18
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
19
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
20
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
21
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
22
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
23
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
24
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
25
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
26
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
27
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
28
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
29
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
30
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
31
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
32
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
33
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Actively Recruiting
34
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
35
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
36
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
37
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
38
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
39
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
40
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
41
The Iowa Clinic PC
West Des Moines, Iowa, United States, 50266
Actively Recruiting
42
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
43
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
44
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
45
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
46
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
47
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
48
Mary Bird Perkins Cancer Center - Gonzales
Gonzales, Louisiana, United States, 70737
Actively Recruiting
49
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States, 70002
Actively Recruiting
50
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
51
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
52
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
53
Trinity Health Medical Center - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
54
Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
55
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
56
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
57
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, United States, 48341
Actively Recruiting
58
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
59
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Active, Not Recruiting
60
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
61
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
62
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
63
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
64
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
65
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
66
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
67
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
68
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
69
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
70
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
71
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
72
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
73
Lake Regional Hospital
Osage Beach, Missouri, United States, 65065
Actively Recruiting
74
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
75
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
76
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
77
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
78
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
79
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
80
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
81
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
82
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
83
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
84
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
85
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
86
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
87
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
88
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Active, Not Recruiting
89
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Active, Not Recruiting
90
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
91
Grant Medical Center
Columbus, Ohio, United States, 43215
Actively Recruiting
92
Doctors Hospital
Columbus, Ohio, United States, 43228
Actively Recruiting
93
Dublin Methodist Hospital
Dublin, Ohio, United States, 43016
Actively Recruiting
94
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States, 44903
Actively Recruiting
95
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Actively Recruiting
96
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
97
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
Actively Recruiting
98
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
99
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States, 18519
Actively Recruiting
100
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
101
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, United States, 16121
Actively Recruiting
102
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Actively Recruiting
103
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
104
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Actively Recruiting
105
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
106
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
107
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
Actively Recruiting
108
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
109
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
110
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
111
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
112
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Actively Recruiting
113
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States, 15301
Actively Recruiting
114
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
Actively Recruiting
115
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
116
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States, 05602
Actively Recruiting
117
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
118
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
119
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States, 23116
Actively Recruiting
120
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States, 23114
Actively Recruiting
121
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States, 23226
Actively Recruiting
122
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States, 23230
Actively Recruiting
123
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
124
VCU Community Memorial Health Center
South Hill, Virginia, United States, 23970
Actively Recruiting
125
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
126
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
127
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States, 54806
Actively Recruiting
128
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H3H 2R9
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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