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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02061761
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Biological: BMS-986016 Biological: BMS-936558 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 13, 2014
Actual Primary Completion Date : February 16, 2022
Actual Study Completion Date : February 16, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A - relatlimab (Dose escalation) Biological: BMS-986016
Specified Dose on Specified Days
Other Name: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab
Experimental: Part C - relatlimab + nivolumab (Dose escalation) Biological: BMS-986016
Specified Dose on Specified Days
Other Name: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab

Biological: BMS-936558
Specified Dose on Specified Days
Other Name: Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106, nivolumab
Experimental: Part B - relatlimab (Cohort expansion) Biological: BMS-986016
Specified Dose on Specified Days
Other Name: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab
Experimental: Part D - relatlimab + nivolumab (Cohort expansion) Biological: BMS-986016
Specified Dose on Specified Days
Other Name: Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3), relatlimab

Biological: BMS-936558
Specified Dose on Specified Days
Other Name: Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106, nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 28 months ]
  2. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
  3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 28 months ]
  4. Incidence of Deaths [ Time Frame: Approximately 28 months ]
  5. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Approximately 28 months ]
  6. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Approximately 28 months ]
  7. Incidence of clinically significant changes in clinical laboratory values: Serology tests [ Time Frame: Approximately 28 months ]
  8. Incidence of clinically significant changes in clinical laboratory values: Endocrine panel [ Time Frame: Approximately 28 months ]
  9. Incidence of clinically significant changes in clinical laboratory values: Urinalysis [ Time Frame: Approximately 28 months ]
  10. Incidence of clinically significant changes in clinical laboratory values: Cardiac Troponin [ Time Frame: Approximately 28 months ]
  11. Objective response rate (ORR) in Part D [ Time Frame: Approximately 4 years ]
    Efficacy measured by proportion of treated subjects with a best overall response of complete response/complete remission (CR) or partial response/partial remission (PR)

  12. Duration of Response (DOR) in Part D [ Time Frame: Approximately 4 years ]
    Efficacy measured by the duration of response for all treated subjects with a best overall response of CR or PR


Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of BMS-986016 administered alone and in combination with Nivolumab [ Time Frame: Approximately 28 months ]
  2. Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  3. Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  4. Concentration at the end of a dosing interval (Ctau) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  5. Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  6. Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  7. Total body clearance (CLT) of BMS-986016 administered both alone alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  8. Effective elimination half-life that explains the degree of AUC administered alone accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  9. Effective elimination half-life that explains the degree of Cmax administered alone accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  10. Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  11. Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  12. Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  13. Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
  14. Incidence of ADA to nivolumab and BMS-986016 [ Time Frame: Approximately 28 Months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061761


Locations
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United States, Maryland
Local Institution - 0007
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Local Institution - 0004
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Local Institution - 0010
Saint Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Oregon
Local Institution - 0002
Portland, Oregon, United States, 97239
United States, Texas
Local Institution - 0006
Houston, Texas, United States, 77030
United States, Washington
Local Institution - 0001
Seattle, Washington, United States, 98109
Canada, British Columbia
Local Institution - 0011
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Local Institution - 0012
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02061761    
Other Study ID Numbers: CA224-022
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Hodgkin lymphoma
non-Hodgkin lymphoma
diffused large B-cell lymphoma
indolent lymphoma
 chronic lymphocytic leukemia
relapsed
refractory
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Nivolumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action