Actively Recruiting
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
320
Participants Needed
132
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitean-hziy to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). 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. Sacituzumab govitean-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitean-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitean-hziy to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitean-hziy may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.
CONDITIONS
Official Title
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Diagnosis of locally advanced (unresectable or not suitable for curative treatment) or metastatic urothelial cancer
- Histologically confirmed conventional urothelial carcinoma with at least 1% urothelial histology; other histologic subtypes allowed except pure non-urothelial tumors
- Measurable disease according to RECIST 1.1 with baseline imaging within 35 days before randomization
- Prior progression on or after immediate previous anti-cancer therapy
- Previous treatment with anti-PD(L)1 therapy, having received at least one dose
- At least one line of systemic therapy for advanced/metastatic disease, except in specific cases of prior anti-PD(L)1 plus enfortumab vedotin with progression within 12 months
- For FGFR3+ tumors, prior FGFR inhibitor treatment unless contraindicated
- Prior exposure to enfortumab vedotin or other Nectin-4 directed or MMAE-containing therapies unless contraindicated
- No prior exposure to sacituzumab govitecan-hziy or other TROP-2 directed therapies containing topoisomerase I inhibitors
- Bellmunt score between 0 and 2
- No history of severe (grade 3 or higher) immune-related adverse events from prior anti-PD1/L1 therapy except controlled endocrinopathies
- Recovery to grade 1 or less from previous significant adverse events except certain neuropathies, alopecia, or non-clinically significant lab abnormalities
- Adequate recovery from any major surgery prior to randomization
- Not pregnant or breastfeeding; effective contraception required for patients of childbearing potential
- Ability and willingness to provide informed consent
- Adequate blood counts and organ function within 14 days prior to randomization (including ANC, platelets, albumin, bilirubin, liver enzymes, creatinine clearance, hemoglobin)
- No known genetic UGT1A1 deficiency
- HIV-infected patients must be on effective antiretroviral therapy with undetectable viral load
- Controlled hepatitis B and C infections as specified
- Patients with treated brain metastases must show no progression and be off high-dose steroids
- Patients with prior or concurrent non-significant malignancies allowed
- Not on systemic immunosuppressive medications exceeding prednisone 10 mg daily, except short steroid bursts and certain steroid routes
- English or Spanish speaking for health-related quality of life assessments
You will not qualify if you...
- Patients younger than 18 years
- ECOG performance status greater than 2
- Pure non-urothelial histology tumors
- Lack of measurable disease per RECIST 1.1
- No prior exposure to anti-PD(L)1 therapy or progression within 12 weeks of starting first anti-PD(L)1 therapy
- No prior systemic therapy in advanced/metastatic setting except specific cases
- Prior treatment with sacituzumab govitecan-hziy or other TROP-2 directed therapies containing topoisomerase I inhibitors
- History of grade 3 or higher immune-related adverse events from anti-PD1/L1 therapy not controlled by hormone therapy
- Unrecovered significant adverse events from previous treatments
- Pregnant or breastfeeding
- Known genetic UGT1A1 deficiency
- Uncontrolled HIV, hepatitis B, or hepatitis C infections
- Active brain metastases or requiring high-dose steroids
- Concurrent malignancies that may interfere with study participation
- Use of systemic immunosuppressive medications exceeding allowed doses
- Non-English or non-Spanish speakers unable to complete quality of life assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 132 locations
1
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
5
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
9
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
10
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
11
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
12
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
13
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
14
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
15
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
16
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
17
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
18
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
19
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
20
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
21
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
22
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
23
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
24
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
25
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
26
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
27
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
28
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
29
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
30
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
31
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
32
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
33
HaysMed
Hays, Kansas, United States, 67601
Actively Recruiting
34
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
35
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
36
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
37
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
38
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
39
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
40
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
41
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
42
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
43
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
44
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
45
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
46
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
47
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
48
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
49
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
50
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
51
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
52
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
53
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
54
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
55
Avera Cancer Institute at Marshall
Marshall, Minnesota, United States, 56258
Actively Recruiting
56
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
57
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
58
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
59
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
60
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
61
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
62
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
63
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
64
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
65
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
66
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
67
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
68
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
69
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
70
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
71
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
72
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
73
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
74
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
75
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
76
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
77
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
78
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
79
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
80
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
81
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
82
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
83
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
84
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
85
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
86
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Actively Recruiting
87
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
88
Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
89
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
90
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
91
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Actively Recruiting
92
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
93
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
94
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
95
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
96
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Actively Recruiting
97
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
98
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
99
IRMC Cancer Center
Indiana, Pennsylvania, United States, 15701
Actively Recruiting
100
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
101
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
102
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
103
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
104
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
105
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
106
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
107
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
108
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
109
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
110
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States, 15301
Actively Recruiting
111
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
112
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
113
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, United States, 57401
Actively Recruiting
114
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, United States, 57301
Actively Recruiting
115
Avera Cancer Institute at Pierre
Pierre, South Dakota, United States, 57501
Actively Recruiting
116
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
117
Avera Cancer Institute at Yankton
Yankton, South Dakota, United States, 57078
Actively Recruiting
118
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States, 05602
Actively Recruiting
119
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
120
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
121
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
122
Virginia Cancer Institute
Richmond, Virginia, United States, 23229
Actively Recruiting
123
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
124
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
125
FHCC Overlake
Bellevue, Washington, United States, 98004
Actively Recruiting
126
FHCC at EvergreenHealth
Kirkland, Washington, United States, 98034
Actively Recruiting
127
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
128
FHCC at Northwest Hospital
Seattle, Washington, United States, 98133
Actively Recruiting
129
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
130
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
Actively Recruiting
131
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
132
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
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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