A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma

Last updated: March 27, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Treatment

Nivolumab

Relatlimab

Clinical Study ID

NCT05255601
CA224-069
2021-000493-29
U1111-1264-4062
2023-503715-14
  • Ages < 30
  • All Genders

Study Summary

The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with pathologically confirmed high-risk R/R cHL, after non-response toor failure of 1or more lines of standard therapy.

  • Participants with pathologically confirmed R/R NHL after non-response to or failureof 1or more lines of standard therapy, including, but not limited to, R/R primarymediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal grayzone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-celllymphoma (PTCL).

  • Participants with pathologically confirmed R/R NHL after non-response to or failureof 2 or more lines of standard therapy, including Burkitt lymphoma (blast count <25%malignant Burkitt cells and/or per the investigator's clinical assessment of riskstatus), lymphoblastic lymphoma (blast count < 25% of marrow nucleated cells and/orper the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cellleukemia/lymphoma subtype).

  • The participant's current disease state must be R/R to standard therapy.

  • Participants must have measurable PET positive disease in both cHL and NHL cohorts.

Exclusion

Exclusion Criteria:

  • Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie,from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or withleptomeningeal seeding.

  • Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cellco-stimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targetedtherapies.

  • Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents.

  • Participants with clinically significant systemic illnesses unrelated to the canceras judged by the investigators, which would compromise the participant's ability totolerate the study treatment.

  • Participants with autoimmune disease.

  • Prior allogeneic bone marrow transplantation.

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Nivolumab
Phase: 1/2
Study Start date:
September 13, 2022
Estimated Completion Date:
July 05, 2028

Connect with a study center

  • Local Institution - 0037

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • University of New South Wales UNSW - Sydney Childrens Hospital SCH - The Centre for Cancer and Blood Disorders

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Local Institution - 0039

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Local Institution

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0042

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perth Childrens Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Perth Childrens Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0063

    Angers, Angers Cedex 9 49933
    France

    Active - Recruiting

  • Groupe Hospitalier Pellegrin - Hopital des enfants

    Bordeaux, 33076
    France

    Active - Recruiting

  • Local Institution - 0048

    Bordeaux, 33076
    France

    Active - Recruiting

  • Local Institution - 0033

    Caen, 14033
    France

    Site Not Available

  • CHU Grenoble Alpes - Hopital Couple Enfant (HCE)

    La Tronche, 38700
    France

    Active - Recruiting

  • Local Institution - 0067

    La Tronche, 38700
    France

    Site Not Available

  • Institut d Hematologie et d Oncologie Pediatriques

    Lyon, 69373 Cedex 08
    France

    Active - Recruiting

  • Local Institution - 0021

    Lyon, 69373 Cedex 08
    France

    Active - Recruiting

  • Local Institution - 0034

    Marseille, 13385
    France

    Site Not Available

  • Local Institution - 0018

    Montpellier, 34295
    France

    Active - Recruiting

  • Local Institution - 0021

    Nimes, 30029
    France

    Site Not Available

  • Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre

    Paris, 75935
    France

    Active - Recruiting

  • Local Institution - 0006

    Paris, 75571
    France

    Active - Recruiting

  • Local Institution - 0047

    Paris, 75935
    France

    Site Not Available

  • Local Institution - 0022

    Rennes, 35203
    France

    Site Not Available

  • CHRU de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67000
    France

    Active - Recruiting

  • Local Institution - 0052

    Strasbourg, 67000
    France

    Site Not Available

  • Local Institution

    Aachen, 52074
    Germany

    Site Not Available

  • Local Institution - 0056

    Aachen, 52074
    Germany

    Site Not Available

  • Local Institution

    Berlin, 13353
    Germany

    Site Not Available

  • Local Institution - 0015

    Berlin, 13353
    Germany

    Site Not Available

  • Local Institution

    Giessen, 35392
    Germany

    Site Not Available

  • Local Institution - 0028

    Giessen, 35392
    Germany

    Site Not Available

  • Local Institution - 0036

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution

    Muenster, 48149
    Germany

    Site Not Available

  • Local Institution - 0008

    Muenster, 48149
    Germany

    Site Not Available

  • Local Institution

    Munich, 80337
    Germany

    Site Not Available

  • Local Institution - 0051

    Munich, 80337
    Germany

    Site Not Available

  • Local Institution - 0041

    Pavia, PV 27100
    Italy

    Site Not Available

  • Local Institution - 0010

    Aviano, 33081
    Italy

    Site Not Available

  • Local Institution - 0007

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139
    Italy

    Active - Recruiting

  • Local Institution - 0040

    Florence, 50139
    Italy

    Active - Recruiting

  • Local Institution - 0005

    Genoa, 16147
    Italy

    Site Not Available

  • Local Institution - 0070

    Milan, 20162
    Italy

    Site Not Available

  • Local Institution

    Milano,
    Italy

    Site Not Available

  • Local Institution - 0001

    Milano, 20133
    Italy

    Active - Recruiting

  • Local Institution - 0043

    Monza, 20900
    Italy

    Active - Recruiting

  • Local Institution - 0013

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Active - Recruiting

  • Local Institution - 0065

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0002

    Roma, 0165
    Italy

    Site Not Available

  • Osp. Pediatrico Bambino Gesu, IRCCS

    Roma, 00165
    Italy

    Active - Recruiting

  • Local Institution - 0004

    Turin, 10126
    Italy

    Active - Recruiting

  • Local Institution - 0057

    Utrecht, 3584 CS
    Netherlands

    Active - Recruiting

  • Princess Maxima Center for pediatric oncology

    Utrecht, 3584 CS
    Netherlands

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Local Institution - 0062

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitari Vall dHebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Local Institution

    Barcelona, 8035
    Spain

    Site Not Available

  • Local Institution - 0009

    Barcelona, 8026
    Spain

    Site Not Available

  • Local Institution - 0046

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Sant Juan de Deu Barcelona

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Local Institution - 0069

    Esplugues de Llobregat, 8950
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Local Institution

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 0030

    Madrid, 28009
    Spain

    Active - Recruiting

  • Local Institution - 0044

    Madrid, 28040
    Spain

    Site Not Available

  • Local Institution - 0045

    Madrid, 28046
    Spain

    Active - Recruiting

  • Local Institution - 0055

    Madrid, 28041
    Spain

    Active - Recruiting

  • Local Institution - 0058

    Madrid, 28027
    Spain

    Active - Recruiting

  • Local Institution - 0011

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio HUVR

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Local Institution

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution - 0023

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Local Institution - 0038

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Local Institution

    Valencia,
    Spain

    Site Not Available

  • Local Institution - 0049

    Valencia, 46026
    Spain

    Active - Recruiting

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Local Institution - 0075

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Site Not Available

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, England L12 2AP
    United Kingdom

    Active - Recruiting

  • Local Institution - 0074

    Liverpool, England L12 2AP
    United Kingdom

    Site Not Available

  • Local Institution - 0054

    London, Londonderry NW1 2PG
    United Kingdom

    Site Not Available

  • UCLH

    London, Londonderry NW1 2PG
    United Kingdom

    Active - Recruiting

  • Local Institution - 0003

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Local Institution - 0050

    Bristol, Somerset BS2 8BJ
    United Kingdom

    Site Not Available

  • Local Institution - 0053

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Local Institution - 0031

    Birmingham, West Midlands B4 6NH
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

    London, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Local Institution - 0068

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Local Institution - 0077

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Lucile Packard Childrens Hospital - Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford University - Lucile Packard Childrens Hospital LPCH

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Local Institution - 0061

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours Childrens Hospital

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Golisano Children&#39,s Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • AdventHealth

    Orlando, Florida 32804
    United States

    Site Not Available

  • Local Institution

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • St. Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • The Johns Hopkins Hospital JHH

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Minnesota Medical School - Masonic Childrens Hospital

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • University Of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Local Institution - 0012

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Siteman Cancer Center - Washington University Medical Campus Location

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0016

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • New York Medical College

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Local Institution - 0019

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center - Penn State Children's Hospital

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Local Institution - 0014

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Dell Children's Medical Center of Central Texas (DCMC) - Strictly Pediatrics Subspecialty Center

    Austin, Texas 78723
    United States

    Site Not Available

  • CHRISTUS Childrens

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • CHRISTUS Santa Rosa Childrens Hospital CSRCH - The Howard A. Britton M.D. Childrens Cancer and Blood Disorders Center

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Local Institution - 0076

    Norfolk, Virginia 23507
    United States

    Site Not Available

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

    Madison, Wisconsin 53792
    United States

    Site Not Available

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