A Phase I Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Immunoregulatory Activity, and Preliminary Antitumor Activity of Anti-Programmed-Death 1 (PD-1) Antibody (Nivolumab, BMS 936558) and the Combination of Nivolumab and Ipilimumab in Subjects with Relapsed or Refractory Hematologic Malignancy
This research is being done to to test the effectiveness, safety, and tolerability of an experimental drug called BMS-936558. BMS wants to find out what effect, good or bad, the study drug has on men and women with multiple myeloma, chronic myelogenous leukemia (CML), Hodgkin lymphoma, primary mediastinal B cell lymphoma (PMBL) or other B or T cell lymphomas. We also want to know if the study drug helps improve the symptoms of multiple myeloma, CML, or lymphoma,and what effect the study drug can have on your body's immune response to your tumor and how your body's immune response may change over the course of your study treatment
Subjects must have diagnosis of: relapsed or refractory B cell lymphoma, primary mediastinal B cell Lymphoma (PMBL), T cell lymphoma, Multiple Myeloma (MM), Hodgkin Lymphoma (HL), or Chronic Myeloind Leukemia Absolute neutrophil count must be greater than 1000/Î¼L and platelet count greater than 50,000/Î¼L. Subjects with myelodysplasia, polycythemia vera, idiopathic thrombocythemia, myelofibrosis, acute leukemias, blast phase CML, T cell lymphoblastic or Burkitt lymphoma are excluded. Subjects with autoimmune disorders are excluded.
Subjects will receive BMS-936558 by intravenous infusion every 2 weeks for up to two years depending upon response.
08/30/2014 04:02 AM