A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2028 → Dec 31, 2030
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Record History

The 50 most recent of 132 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 161 to 162
  2. Study sites revised (161)
  3. Re-verified, no change to tracked fields
  4. Eligibility criteria expanded, about 43 words
    • Site details revised at 18 of 161 sites
    • Study description expanded, about 5 words
  5. Primary and study completion pushed from Dec 31, 2028 to Dec 31, 2030v128
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 160 to 161v127
  2. Site contacts updated at 3 of 160 sitesv126
  3. Study sites: 159 to 160v125
  4. Study sites: 158 to 159v124
  5. Study sites: 159 to 158v123
  6. Study sites revised (159)v122
  7. Study sites revised (159)v121
  8. Re-verified, no change to tracked fieldsv120
  1. Trial sites expanded: 152 → 159 locations
    • Study title revised
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 1 word
    v119
  2. Study sites: 151 to 152v118
  3. Study sites: 150 to 151v117
  4. Study sites: 148 to 150v116
  5. Site contacts updated at 1 of 148 sitesv115
  6. Trial sites expanded: 140 → 148 locationsv114
  7. Study sites: 139 to 140v113
  8. Trial sites expanded: 134 → 137 locationsv112
  9. Study sites: 137 to 138v111
  10. Study sites: 135 to 137v110
  11. Study sites: 134 to 135v109
  12. Study sites: 133 to 134v108
  13. Study sites: 132 to 133v107
  14. Study sites: 131 to 132v106
  15. Re-verified, no change to tracked fieldsv105
  16. Study sites: 130 to 131v104
  17. Trial sites expanded: 114 → 129 locationsv103
  18. Study sites: 114 to 129v102
  19. Study sites: 113 to 114v101
  20. Trial sites expanded: 108 → 111 locationsv100
  21. Study sites: 111 to 112v99
  22. Study sites: 108 to 111v98
  23. Re-verified, no change to tracked fieldsv97
  24. Study sites: 106 to 108v96
  25. Study sites: 105 to 106v95
  26. Re-verified, no change to tracked fieldsv94
  27. Trial sites expanded: 96 → 104 locationsv93
  28. Study sites: 96 to 104v92
  29. 8 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv84-v91
  30. Study sites: 95 to 96v83
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06524544
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov