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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.
NATIONAL TRIAL REFERENCE NUMBER | NCT06459180 | |
Conditions | Cervical Cancer | |
Age Range | 18+ | |
Sex | Female | |
Current trial phase | 1 | |
Trial start and end dates | [07-24-2024] [10-23-2028] |
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Cervical Cancer
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
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.