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Two drugs, nivolumab and relatlimab, to treat Hodgkin lymphoma and non-Hodgkin lymphoma (NHL) that has come back (relapsed) or has not gotten better with treatment (refractory) in children and young adults

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30 and younger

Phase 1, Phase 2

22 Locations

NCT05255601

Clinical Trial Goal


To find out:
  • The highest dose of nivolumab that’s safe to give with relatlimab
  • If the combination of nivolumab and relatlimab is safe and works well to treat lymphoma that has relapsed or is refractory in children and young adults

You may be able to join this trial if you:


  • Are 30 years old or younger
  • Have lymphoma that has relapsed or is refractory. Some examples include:
    • Anaplastic large cell lymphoma (ALCL)
    • Cutaneous T-cell lymphoma (CTCL)
    • Diffuse large B-cell lymphoma (DLBCL)
    • Follicular lymphoma
    • Hodgkin lymphoma
    • Mantle cell lymphoma (MCL)
    • Marginal zone B-cell lymphoma (MZL)
    • Mediastinal gray zone lymphoma (MGZL)
    • Peripheral T-cell lymphoma (PTCL)
    • Primary mediastinal B-cell lymphoma (PMBCL)
    • Small lymphocytic lymphoma (SLL)
    • Waldenström's macroglobulinemia
    • Other T-cell lymphoma
  • Do not have lymphoma that doctors consider aggressive. Some examples include:
    • Burkitt lymphoma
    • Lymphoblastic lymphoma
    • NK cell lymphoma
    • NK cell leukemia
    • T cell leukemia
    • T cell lymphoma
  • Do not have lymphoma in your brain or spinal cord
  • Have not had an autologous (your own cells) or allogeneic (cells from a donor) blood or marrow transplant (BMT)
  • Have not been treated with any of the following. Your doctor can tell you this:
    • An anti-CTLA-4 antibody
    • A drug that targets T-cells
    • A lymphocyte activation gene-3 (LAG-3)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Nivolumab is a checkpoint inhibitor that targets PD-1 on certain cells.
Relatlimab is a monoclonal antibody that targets LAG3 on certain cells.

You'll get: 
  • Nivolumab – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Relatlimab –  Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years. 

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat Hodgkin lymphoma and NHL is new and unproven. 

Contacts


BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Locations

Local Institution - 0077NOT_YET_RECRUITING

Birmingham, Alabama
Site 0077

Local Institution - 0024COMPLETED

Phoenix, Arizona

Local Institution - 0035COMPLETED

Palo Alto, California

Local Institution - 0032COMPLETED

New Haven, Connecticut

Local Institution - 0061WITHDRAWN

Wilmington, Delaware

Local Institution - 0066COMPLETED

Fort Myers, Florida

Local Institution - 0017WITHDRAWN

Orlando, Florida

St. Mary's Medical CenterWITHDRAWN

West Palm Beach, Florida

Local Institution - 0073COMPLETED

Baltimore, Maryland

Local Institution - 0025COMPLETED

Minneapolis, Minnesota

Local Institution - 0020COMPLETED

Jackson, Mississippi

Local Institution - 0012WITHDRAWN

St Louis, Missouri

Local Institution - 0071COMPLETED

Hackensack, New Jersey

Local Institution - 0059COMPLETED

Valhalla, New York

Local Institution - 0060COMPLETED

New York, New York

Local Institution - 0016WITHDRAWN

The Bronx, New York

Local Institution - 0019WITHDRAWN

Hershey, Pennsylvania

Local Institution - 0014WITHDRAWN

Nashville, Tennessee

Local Institution - 0026COMPLETED

San Antonio, Texas

Local Institution - 0029NOT_YET_RECRUITING

Austin, Texas
Site 0029

Local Institution - 0076WITHDRAWN

Norfolk, Virginia

UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant ClinicWITHDRAWN

Madison, Wisconsin

ClinicalTrials.gov record


NCT05255601. First posted on 2/24/22

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