A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

The purpose of this study is to assess the safety and tolerability and preliminary anti-tumor activity of lirilumab/BMS-986015 given in combination with nivolumab/BMS-936558 and to identify dose-limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors.

Inclusion Criteria:

* During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen

* During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens

* Subjects must have measurable disease

Exclusion Criteria:

* Prior therapy with an immune cell modulating antibody except for anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA4)

* Active or chronic autoimmune diseases
Phase I
Multiple Tumor Types
Rachel Sanborn, M.D.
Bristol Myers Squibb (BMS)
Tara Foote
  • Oncology and Hematology Care Eastside