Safety Study of Anti-LAG-3 in CLL, HL, NHL and MM

Status: Recruiting
Phase: Phase 1
Diagnosis: Lymphoma
NCT ID: NCT02061761 (View complete trial on
DFCI Protocol ID:


The purpose of this study is to characterize the safety, tolerability, dose limiting toxicities and maximum tolerated dose of BMS-986016 administered to subjects with relapsed or refractory chronic lymphocytic leukemia, lymphomas and Multiple myeloma


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Philippe Armand, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Kathleen McDermott,

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit Inclusion Criteria: - Part A: - Chronic Lymphocytic Leukemia - Hodgkin Lymphoma - Non Hodgkin Lymphoma - Part B: - Chronic Lymphocytic Leukemia - Hodgkin Lymphoma - Diffuse Large B-cell Lymphoma - Mantle Cell Lymphoma - Progressed, or been refractory to at least one prior standard therapy, including radiation, immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, Alemtuzumab, or Brentuximab) therapy - Not eligible for or declined transplantation or any standard therapy known to be life prolonging or life saving - Subjects without prior exposure to immune cell modulating antibody regimens such as anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD-1), anti-programmed cell death protein ligand 1 (PD-L1), anti-PD-L2, anti-KIR, anti-CD137, or anti-OX40 antibodies. Prior anti-CD20, Alemtuzumab or Brentuximab antibody therapy is allowed - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - At least 1 lesion with measurable disease - Willing to consent to allow a pre-treatment bone marrow biopsy - Willing to consent to a pre-treatment tumor biopsy or allow the acquisition of an existing tumor sample Exclusion Criteria: - Primary cutaneous lymphoma, lymphoproliferative diseases associated with primary immune deficiencies, and lymphomas associated with human immunodeficiency virus (HIV) infection - Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed) - Autoimmune disease
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