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Study identifier: NCT06524544 Synced from ClinicalTrials.gov · July 29, 2026
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A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer

Condition: Locally Advanced Urothelial Carcinoma · Metastatic Urothelial Carcinoma · Unresectable Urothelial Carcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 3
Planned participants320
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (159)

Cancer Center at Saint Joseph'sPhoenix, Arizona, United StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United StatesRecruiting
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
UF Health Cancer Institute - GainesvilleGainesville, Florida, United StatesRecruiting
Emory University Hospital MidtownAtlanta, Georgia, United StatesRecruiting
Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia, United StatesRecruiting
Emory Saint Joseph's HospitalAtlanta, Georgia, United StatesRecruiting
Kootenai Health - Coeur d'AleneCoeur d'Alene, Idaho, United StatesRecruiting
Kootenai Clinic Cancer Services - Post FallsPost Falls, Idaho, United StatesRecruiting
Kootenai Clinic Cancer Services - SandpointSandpoint, Idaho, United StatesRecruiting
University of IllinoisChicago, Illinois, United StatesRecruiting
Carle at The RiverfrontDanville, Illinois, United StatesRecruiting

+ 147 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06524544