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Lymphoma drug combo trial for youth halted after just 5 patients

NCT ID NCT05255601

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a combination of two immune-boosting drugs, relatlimab and nivolumab, in children and young adults with Hodgkin or non-Hodgkin lymphoma that had come back or not responded to treatment. The goal was to check safety, drug levels, and whether the tumors shrank. However, the study was stopped early after enrolling only 5 participants, so we don't have enough information to know if this approach works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
relatlimab and nivolumab (immune-boosting drugs)
What this could lead to
If it had worked, this combination might have offered a new treatment option for young people with lymphoma that didn't respond to standard therapy.
What could go wrong
The trial was terminated early with only 5 participants, so we have very little data. It's too early to know if the combination is safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

5 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma Burkitt lymphoma classic Hodgkin lymphoma diffuse large B-cell lymphoma Hodgkins lymphoma Lymphoma, Extranodal NK-T-Cell lymphoma, non-Hodgkin, familial mature T-cell and NK-cell non-Hodgkin lymphoma non-Hodgkin lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hodgkin disease Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau

    Paris, 75571, France

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

    Paris, 75935, France

  • Azienda Ospedale Universita Padova

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138, Italy

  • CHRU de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67000, France

  • CHU dAngers - Pole Pediatrie

    Angers, Angers Cedex 9, 49933, France

  • Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve

    Montpellier, 34295, France

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan, Milano, 20133, Italy

  • Fondazione MBBM - Clinica Pediatrica

    Monza, 20900, Italy

  • Groupe Hospitalier Pellegrin - Hopital des enfants

    Bordeaux, 33076, France

  • Institut d Hematologie et d Oncologie Pediatriques

    Lyon, 69373 Cedex 08, France

  • Local Institution - 0002

    Roma, 00165, Italy

  • Local Institution - 0004

    Turin, 10126, Italy

  • Local Institution - 0010

    Aviano, 33081, Italy

  • Local Institution - 0020

    Jackson, Mississippi, 39216, United States

  • Local Institution - 0023

    Seville, 41013, Spain

  • Local Institution - 0024

    Phoenix, Arizona, 85016, United States

  • Local Institution - 0025

    Minneapolis, Minnesota, 55454, United States

  • Local Institution - 0026

    San Antonio, Texas, 78207, United States

  • Local Institution - 0029

    Austin, Texas, 78723, United States

  • Local Institution - 0030

    Madrid, Madrid, 28009, Spain

  • Local Institution - 0032

    New Haven, Connecticut, 06510, United States

  • Local Institution - 0033

    Caen, 14033, France

  • Local Institution - 0035

    Palo Alto, California, 94304, United States

  • Local Institution - 0037

    Randwick, New South Wales, 2031, Australia

  • Local Institution - 0040

    Florence, 50139, Italy

  • Local Institution - 0041

    Pavia, 27100, Italy

  • Local Institution - 0042

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0044

    Madrid, 28040, Spain

  • Local Institution - 0045

    Madrid, 28046, Spain

  • Local Institution - 0046

    Barcelona, 08035, Spain

  • Local Institution - 0049

    Valencia, 46026, Spain

  • Local Institution - 0053

    London, SM2 5PT, United Kingdom

  • Local Institution - 0054

    London, Londonderry, NW1 2PG, United Kingdom

  • Local Institution - 0055

    Madrid, 28041, Spain

  • Local Institution - 0058

    Madrid, 28027, Spain

  • Local Institution - 0059

    Valhalla, New York, 10595, United States

  • Local Institution - 0060

    New York, New York, 10032, United States

  • Local Institution - 0062

    Pamplona, 31008, Spain

  • Local Institution - 0066

    Fort Myers, Florida, 33908, United States

  • Local Institution - 0067

    La Tronche, 38700, France

  • Local Institution - 0068

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

  • Local Institution - 0069

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Local Institution - 0070

    Milan, 20162, Italy

  • Local Institution - 0071

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 0073

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0074

    Liverpool, England, L12 2AP, United Kingdom

  • Local Institution - 0075

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Local Institution - 0077

    Birmingham, Alabama, 35233, United States

  • Princess Maxima Center for pediatric oncology

    Utrecht, 3584 CS, Netherlands

  • Royal Childrens Hospital RCH - Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

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