A Phase I 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
BMS-986015 (Anti-KIR) and BMS-936558 (Anti-PD-1) are the experimental drugs not yet approved by the Food and Drug Administration (FDA) and are being developed to treat advanced solid tumors. This is the phase 1 study. The study will enroll the participants with recurrent or treatment-refractory solid tumors ( for the dose escalation phase of the study) and 5 types of malignancies including malignant melanoma, Head and neck Squamous Cell Carcinoma, non-small lung cancer, colorectal cancer, Hepatocellular Carcinoma not amenable to surgical resection ( for the cohort expansion phase of the study). BMS-986015 (Anti-KIR) and BMS-936558 (Anti-PD-1) are the human monoclonal antibodies. An antibody is a type of protein that helps protect the body against foreign matter, such as bacteria and viruses. This type of therapy based on the same idea of the body's natural defense system which protects against various diseases. It may use and enhance the body's own natural ability to defend itself against malignant tumors.
recurrent or refractory cancers, including non-small cell lung cancer, Head and Neck Squamous Cell Carcinoma, malignant melanoma , Hepatocellular Carcinoma not amenable to surgical resection, colorectal cancer. - prior treatment completed at least 4 weeks before study drug is given - good physical condition - good blood counts - no active autoimmune disease - no active infection - no steroid use -may not have had prior therapy with anti-PD-1, or any other T-cell targeted therapy.
The study drugs will be given to you as an intravenous (IV) infusion. This means it will be given as an injection into a vein. Each one will last for about an hour. It may cause some pain. The BMS936558 infusion will be given every 14 days for a total of 4 infusions in each cycle. The BMS986015 infusion will be given on the 1st day and the 15th day for a total of 2 infusion in each cyle and up to 12 cycles may be given. Participants will be required to remain in clinic for up to 1 hour after the completion of the infusions. The expected maximum duration of study drug treatment for a participant is approximately 3 years.
04/17/2014 04:02 AM