Actively Recruiting
A Phase III Randomized Trial of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard Chemotherapy in Advanced Urothelial Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-06-02
320
Participants Needed
148
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.
CONDITIONS
Brief 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
- Patient must have an ECOG performance status of 0 to 2
- Patient must have locally advanced or metastatic urothelial cancer
- Patient must have histologically confirmed conventional urothelial carcinoma with at least 1% conventional urothelial histology
- Patient must have measurable disease per RECIST 1.1 criteria with baseline imaging within 35 days prior to randomization
- Patient must have had progression on or after prior anti-PD(L)1 therapy, having received at least one dose
- Patient must have received at least one line of systemic therapy in the advanced/metastatic setting or have progressed within 12 months after localized anti-PD(L)1 + enfortumab vedotin therapy
- Patients with FGFR3+ tumors must have received a prior FGFR inhibitor unless contraindicated
- Patient must have received prior enfortumab vedotin or other Nectin-4 directed therapy unless contraindicated
- Patient must not have prior exposure to sacituzumab govitecan-hziy or other TROP-2 directed antibody-drug conjugates
- Patient must have a Bellmunt score of 0 to 2
- Patient must not have had grade 3 or higher immune-related adverse events from prior anti-PD1/L1 except for controlled endocrinopathies
- Patient must have recovered from prior treatment-related adverse events to grade 1 or less except for certain neuropathies, alopecia, or non-clinically significant lab abnormalities
- Patient must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential
- Patient must be able and willing to sign informed consent
- Patient must meet specific blood count and organ function criteria within 14 days prior to randomization
- Patient must not have known genetic UGT1A1 deficiency
- HIV-infected patients must be on effective therapy with undetectable viral load
- Patients with hepatitis B or C must meet specific viral load or treatment criteria
- Patients with treated brain metastases must show no progression and no high-dose steroid use
- Patient must not be on systemic immunosuppressive medication exceeding prednisone 10 mg daily
- Patient must be English or Spanish speaking for the quality of life study component
You will not qualify if you...
- Pure non-urothelial histology tumors
- Progression within 12 weeks of starting first anti-PD(L)1 therapy
- History of grade 3 or higher immune-related adverse events from prior anti-PD1/L1 except controlled endocrinopathies
- Unrecovered clinically significant adverse events from previous systemic therapy above grade 1 except certain exceptions
- Pregnancy or breastfeeding
- Known genetic UGT1A1 deficiency (Gilbert's syndrome)
- Active HIV infection without effective therapy or detectable viral load
- Active hepatitis B or C infection not meeting viral load or treatment criteria
- Untreated or progressing brain metastases or use of high-dose steroids for brain metastases
- Use of systemic immunosuppressive medication exceeding prednisone 10 mg daily at enrollment
- Non-English or non-Spanish speakers for quality of life component
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 weeks for chemotherapy or up to 2 years for pembrolizumab and sacituzumab govitecan, depending on treatment arm and participant response
Participants receive either standard chemotherapy with various drugs every 21 days for up to 6 cycles, or receive pembrolizumab and sacituzumab govitecan every 21 days for up to 35 cycles or 2 years. Blood samples and imaging are collected throughout treatment.
Cycles repeat every 21 days with multiple infusion visits per cycle
Duration - Up to 5 years
After treatment completion, participants are followed up at 30 days and then once a year for 5 years from randomization to monitor overall survival and other outcomes.
1 visit at 30 days post-treatment, then annual visits for up to 5 years
Trial Site Locations
Total: 148 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
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
43
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States, 70002
Actively Recruiting
44
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
45
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
46
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
47
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
48
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
49
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
50
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
51
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
52
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
53
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
54
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
55
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
56
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
57
Avera Cancer Institute at Marshall
Marshall, Minnesota, United States, 56258
Actively Recruiting
58
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
59
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
60
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
61
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
62
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
63
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
64
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
65
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
66
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
67
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
68
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
69
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
70
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
71
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
72
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
73
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
74
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
75
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
76
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
77
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
78
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
79
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
80
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
81
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
82
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
83
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
84
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
85
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
86
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
87
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
88
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
89
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Actively Recruiting
90
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
91
Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
92
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
93
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
94
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Actively Recruiting
95
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
96
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
97
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
98
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States, 18519
Actively Recruiting
99
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
100
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
101
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Actively Recruiting
102
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
103
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
104
IRMC Cancer Center
Indiana, Pennsylvania, United States, 15701
Actively Recruiting
105
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
106
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Actively Recruiting
107
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
108
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
109
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
110
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
111
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
112
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
113
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
114
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
115
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
116
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States, 15301
Actively Recruiting
117
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
118
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
119
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
120
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, United States, 57401
Actively Recruiting
121
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, United States, 57301
Actively Recruiting
122
Avera Cancer Institute at Pierre
Pierre, South Dakota, United States, 57501
Actively Recruiting
123
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
124
Avera Cancer Institute at Yankton
Yankton, South Dakota, United States, 57078
Actively Recruiting
125
Houston Methodist San Jacinto Hospital
Baytown, Texas, United States, 77521
Actively Recruiting
126
Houston Methodist Cypress Hospital
Cypress, Texas, United States, 77429
Actively Recruiting
127
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
128
Methodist Willowbrook Hospital
Houston, Texas, United States, 77070
Actively Recruiting
129
Houston Methodist West Hospital
Houston, Texas, United States, 77094
Actively Recruiting
130
Houston Methodist Saint John Hospital
Nassau Bay, Texas, United States, 77058
Actively Recruiting
131
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States, 77479
Actively Recruiting
132
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States, 77385
Actively Recruiting
133
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States, 05602
Actively Recruiting
134
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
135
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
136
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
137
Virginia Cancer Institute
Richmond, Virginia, United States, 23229
Actively Recruiting
138
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
139
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
140
FHCC Overlake
Bellevue, Washington, United States, 98004
Actively Recruiting
141
FHCC at EvergreenHealth
Kirkland, Washington, United States, 98034
Actively Recruiting
142
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
143
FHCC at Northwest Hospital
Seattle, Washington, United States, 98133
Actively Recruiting
144
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
145
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
Actively Recruiting
146
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
147
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
148
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
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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