NCT06963905

Saci Nivo Rela for TNBC

Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Patients will be followed up for up to two years. Their safety will be monitored, and tumor response will be regularly evaluated by RECIST 1.1 criteria every nine weeks. The primary endpoint includes safety as the incidence of dose-limiting toxicities (DLT) in three weeks after C1D1. Secondary endpoints include overall response rate (defined as either complete response or partial response), duration of response, clinical benefit rate, progression free survival, and safety (TEAE) with sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus nivolumab + relatlimab FDC. Exploratory endpoints include overall survival, and biomarkers of prediction of response will be also evaluated. There will be a 135-day (+7 days) follow-up visit after the last study treatment administration or before starting a new anticancer treatment, whichever occurs first, followed by long-term/survival chart review follow-up every three months (±14 days) from the date of the 135-day (+7 days) follow-up visit for two years.

Conditions

• Metastatic Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Relatlimab FDC + Nivolumab	Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W
DRUG	Sacituzumab Govitecan (SG)	10 mg/kg IV D1 \& D8 every 21-day cycles (Dose level 1); 7.5 mg/kg IV D1 \& D8 every 21-day cycles (Dose level -1); 5 mg/kg IV D1 \& D8 every 21-day cycles 21-day cycles (Dose level -2)
DRUG	Nivolumab	360mg IV Q3W

Timeline

• Start date: 2025-12-29
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-05-09
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study