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Safety Study of Anti-LAG-3 in Relapsed or Refractory Hematologic Malignancies

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 and maximum tolerated dose of BMS-986016 administered alone or in combination with Nivolumab to subjects with relapsed hematologic malignancies.


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: - For dose escalation monotherapy: CLL, HL, NHL, MM - For dose expansion monotherapy: CLL, HL, NHL - For dose escalation and dose expansion in combination with BMS-936558: HL and DLBCL - Progressed, or been intolerant to, at least one standard treatment regimen - Not eligible for or declined transplantation or any standard therapy known to be life prolonging or life saving - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - At least 1 lesion with measurable disease at baseline - Availability of an existing tumor biopsy sample (or consent to allow pre-treatment tumor biopsy if sample not available) Exclusion Criteria: - 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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