Saci Nivo Rela for Metastatic Triple-Negative Breast Cancer
This study is testing new combinations of medicines for people with metastatic triple-negative breast cancer (cancer that has spread and doesn't have certain receptors). You might receive sacituzumab govitecan (SG) plus nivolumab, or sacituzumab govitecan plus a combination of nivolumab and relatlimab. Researchers want to see how safe these combinations are and if they cause side effects. They will also look at how well the treatments work to shrink tumors. To join, you must be at least 18 years old and have metastatic triple-negative breast cancer that has been previously treated with chemotherapy. The study plans to enroll 60 participants.
- Study design
- This is a randomized, open-label, phase Ib study involving about 60 participants. You would be assigned to one of the treatment groups by chance, and both you and your doctors will know which treatment you are receiving.
- What's involved
- Treatment will continue until your disease progresses, side effects are too severe, or you withdraw from the study. Your safety will be monitored, and tumor responses will be checked every nine weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to two years after treatment to monitor your health and tumor response.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Saci Nivo Rela for TNBC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Adriana Kahn, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinationsThree weeks post-Cycle 1 Day 1 (each cycle is 21 days)
The primary outcome measure is the incidence of dose-limiting toxicities (DLTs) observed three weeks after the first cycle of treatment with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination in patients with advanced triple-negative breast cancer in the second-line setting. The assessment will include the frequency and severity of DLTs to evaluate the safety and tolerability of the treatment regimens.