Conditions
Cervical Cancer
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.
NATIONAL TRIAL REFERENCE NUMBER
NCT06459180
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
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.
Age Range
18+
Sex
Female
About The Study
Trial Phase
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 start and end dates
- Actual study start date July 24, 2024
- Estimated primary completion date October 23, 2028
- Estimated study completion date October 23, 2028
Trial Locations
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.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risksRiskChance (likelihood) for an event, reaction or health problem to happen and possible benefits are for participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant.
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about