A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Public ClinicalTrials.gov record NCT06524544. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan-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 govitecan-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan-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 govitecan-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.
Study identification
- NCT ID
- NCT06524544
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Carboplatin Drug
- Cisplatin Drug
- Computed Tomography Procedure
- Docetaxel Drug
- Gemcitabine Drug
- Magnetic Resonance Imaging Procedure
- Paclitaxel Drug
- Pembrolizumab Biological
- Questionnaire Administration Other
- Sacituzumab Govitecan Biological
Procedure · Drug · Biological + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2025
- Primary completion
- Dec 30, 2030
- Completion
- Dec 30, 2030
- Last update posted
- Aug 27, 2026
2025 – 2030
United States locations
- U.S. sites
- 161
- U.S. states
- 30
- U.S. cities
- 129
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | Recruiting |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | Recruiting |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | Recruiting |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | Recruiting |
| University of Illinois | Chicago | Illinois | 60612 | Recruiting |
| Carle at The Riverfront | Danville | Illinois | 61832 | Recruiting |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | Recruiting |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | Recruiting |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | Recruiting |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | Recruiting |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | Recruiting |
| Carle BroMenn Medical Center | Normal | Illinois | 61761 | Recruiting |
| Carle Cancer Institute Normal | Normal | Illinois | 61761 | Recruiting |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | Recruiting |
| HSHS Saint Elizabeth's Hospital | O'Fallon | Illinois | 62269 | Recruiting |
| Memorial Hospital East | Shiloh | Illinois | 62269 | Recruiting |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | Recruiting |
| Springfield Clinic | Springfield | Illinois | 62702 | Recruiting |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | Recruiting |
| Carle Cancer Center | Urbana | Illinois | 61801 | Recruiting |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | Recruiting |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | Recruiting |
| McFarland Clinic - Boone | Boone | Iowa | 50036 | Suspended |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | Recruiting |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | Recruiting |
| McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa | 50501 | Recruiting |
| McFarland Clinic - Jefferson | Jefferson | Iowa | 50129 | Suspended |
| McFarland Clinic - Marshalltown | Marshalltown | Iowa | 50158 | Recruiting |
| HaysMed | Hays | Kansas | 67601 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | Recruiting |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | Recruiting |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | Recruiting |
| Salina Regional Health Center | Salina | Kansas | 67401 | Recruiting |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | Recruiting |
| UofL Health Medical Center Northeast | Louisville | Kentucky | 40245 | Recruiting |
| Louisiana Hematology Oncology Associates LLC | Baton Rouge | Louisiana | 70809 | Recruiting |
| Mary Bird Perkins Cancer Center - Metairie | Metairie | Louisiana | 70002 | Recruiting |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | Recruiting |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | Recruiting |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | Recruiting |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | Recruiting |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | Recruiting |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | Recruiting |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | Recruiting |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | Recruiting |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | Recruiting |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | Recruiting |
| Avera Cancer Institute at Marshall | Marshall | Minnesota | 56258 | Recruiting |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | Recruiting |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | Recruiting |
| Regions Hospital | Saint Paul | Minnesota | 55101 | Recruiting |
| United Hospital | Saint Paul | Minnesota | 55102 | Recruiting |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | Recruiting |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | Recruiting |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | Recruiting |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | Recruiting |
| University of Kansas Cancer Center - Briarcliff | Kansas City | Missouri | 64116 | Recruiting |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | Recruiting |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | Recruiting |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | Recruiting |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | Recruiting |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | Recruiting |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | Recruiting |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | Recruiting |
| Logan Health Medical Center | Kalispell | Montana | 59901 | Recruiting |
| Community Medical Center | Missoula | Montana | 59804 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | Recruiting |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | Recruiting |
| Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | 08876 | Recruiting |
| Community Medical Center | Toms River | New Jersey | 08755 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | Recruiting |
| Roswell Park Amherst Center | Williamsville | New York | 14221 | Recruiting |
| Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | Recruiting |
| Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | 58103 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Recruiting |
| Geisinger Cancer Center Dickson City | Dickson City | Pennsylvania | 18519 | Recruiting |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | Recruiting |
| Saint Vincent Hospital | Erie | Pennsylvania | 16544 | Recruiting |
| UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | Recruiting |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | 17109 | Recruiting |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | Recruiting |
| IRMC Cancer Center | Indiana | Pennsylvania | 15701 | Recruiting |
| Jefferson Hospital | Jefferson Hills | Pennsylvania | 15025 | Recruiting |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | Recruiting |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion | Mechanicsburg | Pennsylvania | 17050 | Recruiting |
| Forbes Hospital | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| Allegheny Valley Hospital | Natrona Heights | Pennsylvania | 15065 | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| UPMC-Saint Margaret | Pittsburgh | Pennsylvania | 15215 | Recruiting |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC-Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | Recruiting |
| UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania | 16346 | Recruiting |
| UPMC Cancer Center-Uniontown | Uniontown | Pennsylvania | 15401 | Recruiting |
| UPMC Cancer Center-Washington | Washington | Pennsylvania | 15301 | Recruiting |
| Reading Hospital | West Reading | Pennsylvania | 19611 | Recruiting |
| Wexford Health and Wellness Pavilion | Wexford | Pennsylvania | 15090 | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | Recruiting |
| Avera Cancer Institute-Aberdeen | Aberdeen | South Dakota | 57401 | Recruiting |
| Avera Cancer Institute - Mitchell | Mitchell | South Dakota | 57301 | Recruiting |
| Avera Cancer Institute at Pierre | Pierre | South Dakota | 57501 | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | Recruiting |
| Avera Cancer Institute at Yankton | Yankton | South Dakota | 57078 | Recruiting |
| Houston Methodist San Jacinto Hospital | Baytown | Texas | 77521 | Recruiting |
| Houston Methodist Cypress Hospital | Cypress | Texas | 77429 | Recruiting |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | Recruiting |
| UT Southwestern Simmons Cancer Center - RedBird | Dallas | Texas | 75237 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas | 76104 | Recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Recruiting |
| Methodist Willowbrook Hospital | Houston | Texas | 77070 | Recruiting |
| Houston Methodist West Hospital | Houston | Texas | 77094 | Recruiting |
| Houston Methodist Saint John Hospital | Nassau Bay | Texas | 77058 | Recruiting |
| UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas | 75080 | Recruiting |
| Houston Methodist Sugar Land Hospital | Sugar Land | Texas | 77479 | Recruiting |
| Houston Methodist The Woodlands Hospital | The Woodlands | Texas | 77385 | Recruiting |
| Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners | Vermont | 05602 | Recruiting |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | Recruiting |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | Recruiting |
| Hematology Oncology Associates of Fredericksburg Inc | Fredericksburg | Virginia | 22408 | Recruiting |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | Recruiting |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | Recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
| FHCC Overlake | Bellevue | Washington | 98004 | Recruiting |
| FHCC at EvergreenHealth | Kirkland | Washington | 98034 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
| FHCC at Northwest Hospital | Seattle | Washington | 98133 | Recruiting |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | Recruiting |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | Recruiting |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | Recruiting |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | Recruiting |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | Recruiting |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06524544, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06524544 live on ClinicalTrials.gov.