Clinical trial
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (Relatlimab, BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies
Name
CA224-022
Description
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)
Trial arms
Trial start
2014-03-13
Estimated PCD
2022-02-16
Trial end
2022-02-16
Status
Completed
Phase
Early phase I
Treatment
BMS-986016
Specified Dose on Specified Days
Arms:
Part A - relatlimab (Dose escalation), Part B - relatlimab (Cohort expansion), Part C - relatlimab + nivolumab (Dose escalation), Part D - relatlimab + nivolumab (Cohort expansion)
Other names:
Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab
BMS-936558
Specified Dose on Specified Days
Arms:
Part C - relatlimab + nivolumab (Dose escalation), Part D - relatlimab + nivolumab (Cohort expansion)
Other names:
Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106, nivolumab
Size
106
Primary endpoint
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
From first dose to 100 days post last dose (Up to 51 months)
Number of Participants Who Died
From first dose to 135 days post last dose (Up to 52 months)
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
From first dose to 30 days post last dose (Up to 49 months)
Objective Response Rate (ORR) - Part D
From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)
Duration of Response (DoR) - Part D
From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 106, 'type': 'ACTUAL'}}
Updated at
2023-03-24
1 organization
2 products
1 indication
Organization
Bristol-Myers SquibbProduct
BMS-986016Indication
Hematologic NeoplasmsProduct
BMS-936558