A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
NCT ID: NCT02061761
Last Updated: 2023-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
106 participants
INTERVENTIONAL
2014-03-13
2022-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A - relatlimab (Dose escalation)
BMS-986016
Specified Dose on Specified Days
Part C - relatlimab + nivolumab (Dose escalation)
BMS-986016
Specified Dose on Specified Days
BMS-936558
Specified Dose on Specified Days
Part B - relatlimab (Cohort expansion)
BMS-986016
Specified Dose on Specified Days
Part D - relatlimab + nivolumab (Cohort expansion)
BMS-986016
Specified Dose on Specified Days
BMS-936558
Specified Dose on Specified Days
Interventions
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BMS-986016
Specified Dose on Specified Days
BMS-936558
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0007
Baltimore, Maryland, United States
Local Institution - 0004
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution - 0010
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Local Institution - 0002
Portland, Oregon, United States
Local Institution - 0006
Houston, Texas, United States
Local Institution - 0001
Seattle, Washington, United States
Local Institution - 0011
Vancouver, British Columbia, Canada
Local Institution - 0012
Toronto, Ontario, Canada
Countries
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References
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Gopal AK, Armand P, Neelapu SS, Bartlett NL, Spurgeon SE, Kuruvilla J, Savage KJ, Leonard JP, Gelb AB, Ahmed N, Dong S, Bathena SP, Suryawanshi R, Wu JQ, Wang S, Gladstone DE. Nivolumab plus relatlimab for patients with relapsed or progressed B-cell malignancies in RELATIVITY-022. Blood Adv. 2025 Jul 8;9(13):3383-3394. doi: 10.1182/bloodadvances.2024015086.
El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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CA224-022
Identifier Type: -
Identifier Source: org_study_id
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