A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hematologic Neoplasms

Treatments: Biological: BMS-986016; Biological: BMS-936558

Study type: Interventional

Funder types: Industry

Identifiers

NCT02061761

CA224-022

Details and patient eligibility

About

The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
• Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
• Must be more than 100 days post autologous transplant

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)
• Known or suspected autoimmune disease
• History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 4 patient groups

Part A - relatlimab (Dose escalation)

Experimental group

Treatment:

Biological: BMS-986016

Part C - relatlimab + nivolumab (Dose escalation)

Experimental group

Treatment:

Biological: BMS-936558

Biological: BMS-986016

Part B - relatlimab (Cohort expansion)

Experimental group

Treatment:

Biological: BMS-986016

Part D - relatlimab + nivolumab (Cohort expansion)

Experimental group

Treatment:

Biological: BMS-936558

Biological: BMS-986016