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 (SIMONE)

NCT06963905 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Yale University
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	60
Start date	2025-12-29
Completion	2030-12

Conditions

• Metastatic Triple-negative Breast Cancer

Interventions

• Relatlimab FDC + Nivolumab
• Sacituzumab Govitecan (SG)
• Nivolumab

Primary outcomes

• Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations — Three 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.

Countries

United States