A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
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ClinicalTrials.gov Identifier: NCT02061761 |
Recruitment Status :
Completed
First Posted : February 13, 2014
Last Update Posted : June 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematologic Neoplasms | Biological: BMS-986016 Biological: BMS-936558 | Phase 1 Phase 2 |
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 |

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 |
- Incidence of Adverse Events (AEs) [ Time Frame: Approximately 28 months ]
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 28 months ]
- Incidence of Deaths [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Serology tests [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Endocrine panel [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis [ Time Frame: Approximately 28 months ]
- Incidence of clinically significant changes in clinical laboratory values: Cardiac Troponin [ Time Frame: Approximately 28 months ]
- 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)
- 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
- Maximum observed serum concentration (Cmax) of BMS-986016 administered alone and in combination with Nivolumab [ Time Frame: Approximately 28 months ]
- Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
- Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
- 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 ]
- 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 ]
- 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 ]
- Total body clearance (CLT) of BMS-986016 administered both alone alone and in combination with Nivolumab [ Time Frame: Approximately 28 Months ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Incidence of ADA to nivolumab and BMS-986016 [ Time Frame: Approximately 28 Months ]

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

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
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hodgkin lymphoma non-Hodgkin lymphoma diffused large B-cell lymphoma indolent lymphoma |
chronic lymphocytic leukemia relapsed refractory |
Hematologic Neoplasms Neoplasms Neoplasms by Site Hematologic Diseases Nivolumab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |