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Evaluating a new treatment for pediatric and young adult lymphoma

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT05255601

This study is testing a new combination of two drugs to see if they can help young patients with lymphoma who haven't responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment68 (estimated)
AgesN/A to 30 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsrelatlimab, nivolumab
Locations76 sites (Birmingham, Alabama and 75 other locations)
Trial IDNCT05255601 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, drug levels, and preliminary efficacy of the combination of relatlimab and nivolumab in pediatric and young adult patients with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma. Participants must have previously failed one or more lines of standard therapy. The study aims to gather data on how well these drugs work together in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are pediatric and young adult patients with recurrent or refractory Hodgkin or non-Hodgkin lymphoma who have not responded to previous treatments.

Not a fit: Patients with newly diagnosed lymphoma or those who have not yet undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for young patients with difficult-to-treat lymphomas.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in treating lymphomas, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

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 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 this trial is running

Birmingham, Alabama and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-HodgkinHodgkin DiseasePediatricRelatlimabNivolumabLymphocyte Activation Gene-3Lymphoma, Large B-Cell, DiffusePrimary Mediastinal B-cell Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.