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This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician’s choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.
The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
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national trial reference number | NCT06459180 |
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Conditions |
Cervical Cancer
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Age Range | 18+ |
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Sex | Female |
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Current trial phase | 3 |
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Trial start and end dates |
07-24-2024 10-23-2028 |
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.