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Title:
A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Protocol Number:
J13101
Phase:
Phase I
Physician:
Charles Drake
Purpose:
The main purpose of this study is to test the safety and tolerability of the investigational drug called BMS-986016 (also known as anti-LAG-3) given alone in Part A of the study or in combination with another investigational drug called Nivolumab (also known as BMS-936558) in Part B of the study.BMS-986016 (Anti-LAG-3) 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 4 types of malignancies including malignant melanoma, non-small lung cancer, HPV positive head and neck cancers and gastric adenocarcinoma (for the cohort expansion phase of the study). BMS-986016 (Anti-LAG-3) 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 is 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.
Eligibility:
Part A: All solid tumor types, except those with primary CNS involvement, must not have been treated with any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies), must allow pre-treatment biopsy to be done Part B: All solid tumor types, except those with primary CNS involvement, most recent therapy was anti-PD-1 or an anti-PD-1-L1, or all others who have never been treated with any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies) must allow pre-treatment biopsy to be done Part C: Melanoma patients who have never received any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies) or those patients whose most recent therapy was with an anti-PD-1 or anti-PD-l1 therapy, must allow pre-treatment and on treatment biopsies to be done Non-small cell lung cancer, who have never received any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies)or those patients whose most recent therapy was with an anti-PD-1 or anti-PD-l1 therapy, if no accessible archive tumor tissue then pre-treatment biopsy is required HPV positive head and neck cancer patients who have never received any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies) must allow pre-treatment and on treatment biopsies to be done Gastric adenocarnoma patients who have never received any immune cell modulating antibody regimen (Ipi, anti-PD-1, anti-PD1-L1, anti-PD-1L2, Anti KIR, Anti CD137 and/or anti OX40 antibodies) , if no accessible archive tumor tissue then pre-treatment biopsy is required For all Parts: 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, less than 5 prior treatments but a minimum of 1, good thyroid function (with ot without medication)
Treatment:
It is a 3 part study. Part A, BMS-986016 (anti-LAG-3) is given alone. Part B - BMS986016 (anti-LAG-3) will be given with Nivolumab (BMS936558/Anti-PD-1). Part C -BMS986016 (anti-LAG-3) will be given with Nivolumab (BMS936558/Anti-PD-1) in dose levels determined in Part B. 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. Infusions will be given every 14 days for a total of 4 infusions in each cycle. May have up to 12 cycles. Patient must remain in clinic for 1 hour observation period after completion of the dose.
Population:
Adult
Last Update
09/21/2014 04:03 AM
 

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