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
Yale University
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.
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 followe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 (define…
Interventions
- DrugRelatlimab FDC + Nivolumab
Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W
- DrugSacituzumab 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)
- DrugNivolumab
360mg IV Q3W
Location
- Yale UniversityNew Haven, Connecticut