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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06459180
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Not yet recruiting
Phase Phase 3
Start date July 5, 2024
Completion date October 23, 2028

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