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

Stopped early · Phase 1/Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Hodgkin Disease

In brief

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.

Key facts

Study ID

NCT05255601

Run by

Bristol-Myers Squibb

People needed

5

Starts

2022-09-13

Expected to finish

2025-12-03

Last updated by the study team

2026-06-26

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy.
• Participants with pathologically confirmed R/R NHL after non-response to or failure of 1or more lines of standard therapy, including, but not limited to, R/R primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).
• Participants with pathologically confirmed R/R NHL after non-response to or failure of 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 risk status), lymphoblastic lymphoma (blast count < 25% of marrow nucleated cells and/or per 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-cell leukemia/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.

You may not qualify if…

• 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 with leptomeningeal 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-cell co-stimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies.
• Prior treatment with lymphocyte activation gene-3 (LAG-3)-targeted agents.
• Participants with clinically significant systemic illnesses unrelated to the cancer as judged by the investigators, which would compromise the participant's ability to tolerate the study treatment.
• Participants with autoimmune disease.
• Prior allogeneic bone marrow transplantation.
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0024 — Phoenix, Arizona, United States
• Local Institution - 0035 — Palo Alto, California, United States
• Local Institution - 0032 — New Haven, Connecticut, United States
• Local Institution - 0066 — Fort Myers, Florida, United States
• Local Institution - 0073 — Baltimore, Maryland, United States
• Local Institution - 0025 — Minneapolis, Minnesota, United States
• Local Institution - 0020 — Jackson, Mississippi, United States
• Local Institution - 0071 — Hackensack, New Jersey, United States
• Local Institution - 0060 — New York, New York, United States
• Local Institution - 0059 — Valhalla, New York, United States
• Local Institution - 0029 — Austin, Texas, United States
• Local Institution - 0026 — San Antonio, Texas, United States
• Local Institution - 0037 — Randwick, New South Wales, Australia
• Royal Childrens Hospital RCH - Queensland Childrens Hospital — South Brisbane, Queensland, Australia
• Local Institution - 0042 — Nedlands, Western Australia, Australia
• CHU dAngers - Pole Pediatrie — Angers, Angers Cedex 9, France
• Groupe Hospitalier Pellegrin - Hopital des enfants — Bordeaux, France
• Local Institution - 0033 — Caen, France
• Local Institution - 0067 — La Tronche, France
• Institut d Hematologie et d Oncologie Pediatriques — Lyon, France
• Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve — Montpellier, France
• Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau — Paris, France
• Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre — Paris, France
• CHRU de Strasbourg-Hopital de Hautepierre — Strasbourg, France
• Local Institution - 0077 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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