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

Overview

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
SparkCures ID 644
Trial Phase Phase 1
Enrollment 88 Patients
Treatments
  • BMS-986016
Trial Sponsors
  • Bristol Myers Squibb
NCT Identifier

NCT02061761

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Part A:
    • Chronic Lymphocytic Leukemia
    • Hodgkin Lymphoma
    • Non Hodgkin Lymphoma
    • Multiple Myeloma
  • Part B:
    • Chronic Lymphocytic Leukemia
    • Hodgkin Lymphoma
    • Diffuse Large B-cell Lymphoma
    • Mantle Cell Lymphoma
    • Multiple Myeloma
  • 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
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  • MGUS, smoldering myeloma or Waldenström's macroglobulinuria
  • Active plasma cell leukemia
  • 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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