Saci Nivo Rela for TNBC

This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. The study treatment will be continued until the progression of disease, unacceptable toxicity, death, or withdrawal of consent for any reason.

NCT Number	NCT06963905
Lead Sponsor	Yale University Collaborators: Bristol-Myers Squibb
Conditions	Metastatic Triple-negative Breast Cancer
Enrollment	60 participants
Start Date	2025-12-29
Primary Completion	2030-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-22