MK-2870-020
A Study to Compare Sacituzumab Tirumotecan Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer
Active, Not Recruiting
Trial Purpose
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.
View more trial information on ClinicalTrials.gov
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National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. | NCT06459180 |
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MSD Protocol ID |
MK-2870-020 |
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Conditions |
Cervical Cancer |
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Age Range |
18+ |
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SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. | FEMALE |
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Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. | 3 |
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Start Date End Date |
2024-07-24 2028-06-15 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Cervical Cancer
Trial Phase 3
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 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. 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.
Trial Locations
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What can you do next?
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