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 routin
| Condition(s) | Metastatic Triple-negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests. 2. Participants 18 years or older. 3. Pathologically documented breast cancer that: 1. Is defined as unresectable/metastatic disease. 2. Is Human Epidermal Growth Factor Receptor 2 (HER2)-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative, and estrogen receptor (ER)- and progesterone receptor (PgR)- negative, both defined as IHC \<10% 3. Any PD-L1 status measured by IHC via CPS by IHC (defined by the number of PD-L1 staining cells \[tumor cells, lymphocytes, macrophages\] divided by the total number of viable tumor cells, multiplied by 100) via FDA-approved SP263 assay. 4. Has been treated with up t |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Yale University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2025-12-29 |
| NCT ID | NCT06963905 |
| Official listing | https://clinicaltrials.gov/study/NCT06963905 |