Wednesday, September 10, 2014

Anti-KIR (lirilumab) with Nivo - New Trial!!!

A phase I dose escalation and cohort expansion study of lirilumab (anti-KIR, BMS-986015) in combination with Nivolumab (anti-PD-1, BMS-936558, ONO-4538) in advanced solid tumors.

Abstract from ASCO 2014 - Segal, Hodi, Sanborn, Wolchok, Topalian, et al.

Killer cell immunoglubulin-like receptor (KIR) and programmed death-1 (PD-1) are immune receptors that down regulate natural killer (NK) cells and T-cell activity.  Immune checkpoint blockade is emerging as a novel form of cancer immunotherapy.  Lirilumab, an anti-KIR antibody, potentiates NK actitivity and innate immunity, with only modest side effects per a phase I monotherapy trial.  Nivo, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, potentiates T-cell activity and adaptive immunity, and has shown durable activity in various solid tumors, including melanoma, kidney cancer and non-small cell lung cancer.  We hypothesize that [together...they will result] in greater clinical activity than with either agent alone.

This is the first collaborative trial to be conducted by the International Immuno-Oncology Network.  150 patients with any solid tumor (excluding primary central nervous system tumors) will be given Nivo at 3mg/kg IV q2wks plus lirilumab 0.1, 0.3, 1, or 3mg/kg q4wks, in 8 week cycles (max 12).  Primary objectives are to determine safety, tolerability, dose limiting toxicities, and max tolerated dose of the combo.  Secondary objectives = anti-tumor activity, drug action, and immunogenicity, as well as effects on tumor infiltrating lymphocyte subsets in melanoma and squamous cell carcinoma patients.  Exploratory objectives include assessment of innate and adaptive immune responses in peripheral blood and/or tumor specimens and correlation with clinical outcomes.

Trial info -NCT01714739

Still recruiting as of August update!! Locations in the US = University of Chicago - IL, John Hopkins - Maryland, Dana-Farber - Mass, Sloan Kettering - NY, Providence Portland - Oregon.

Wishing my best to all the ratties!!! - c

No comments:

Post a Comment