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Lymphoma, Non-HodgkinPhase 1/2RELATIVITY-069NCT05255601

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

A Phase 1/2 study testing Relatlimab and Nivolumab in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Bristol-Myers Squibb at 51 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 30 years
Conditions the study is for
Lymphoma, Non-Hodgkin, Hodgkin Disease
What is being tested?
Relatlimab and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
51 sitesin 7 countries
Study dates
13 Sep 2022to 3 Dec 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

51 sites in 7 countries.

51 sites in 7 countries

United States13 sites
  • Local Institution - 0029

    Austin, Texas, 78723

  • Local Institution - 0073

    Baltimore, Maryland, 21287

  • Local Institution - 0077

    Birmingham, Alabama, 35233

  • Local Institution - 0066

    Fort Myers, Florida, 33908

  • Local Institution - 0071

    Hackensack, New Jersey, 07601

  • Local Institution - 0020

    Jackson, Mississippi, 39216

  • Local Institution - 0025

    Minneapolis, Minnesota, 55454

  • Local Institution - 0032

    New Haven, Connecticut, 06510

  • Local Institution - 0060

    New York, New York, 10032

  • Local Institution - 0035

    Palo Alto, California, 94304

  • Local Institution - 0024

    Phoenix, Arizona, 85016

  • Local Institution - 0026

    San Antonio, Texas, 78207

  • Local Institution - 0059

    Valhalla, New York, 10595

Other trials in United States

Italy10 sites
  • Local Institution - 0010

    Aviano, 33081

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138

  • Local Institution - 0040

    Florence, 50139

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan, Milano, 20133

  • Local Institution - 0070

    Milan, 20162

  • Fondazione MBBM - Clinica Pediatrica

    Monza, 20900

  • Azienda Ospedale Universita Padova

    Padova, 35128

  • Local Institution - 0041

    Pavia, 27100

  • Local Institution - 0002

    Roma, 00165

  • Local Institution - 0004

    Turin, 10126

Other trials in Italy

Spain10 sites
  • Local Institution - 0046

    Barcelona, 08035

  • Local Institution - 0069

    Esplugues de Llobregat, Barcelona, 08950

  • Local Institution - 0030

    Madrid, Madrid, 28009

  • Local Institution - 0058

    Madrid, 28027

  • Local Institution - 0044

    Madrid, 28040

  • Local Institution - 0055

    Madrid, 28041

  • Local Institution - 0045

    Madrid, 28046

  • Local Institution - 0062

    Pamplona, 31008

  • Local Institution - 0023

    Seville, 41013

  • Local Institution - 0049

    Valencia, 46026

Other trials in Spain

France9 sites
  • CHU dAngers - Pole Pediatrie

    Angers, Angers Cedex 9, 49933

  • Groupe Hospitalier Pellegrin - Hopital des enfants

    Bordeaux, 33076

  • Local Institution - 0033

    Caen, 14033

  • Local Institution - 0067

    La Tronche, 38700

  • Institut d Hematologie et d Oncologie Pediatriques

    Lyon, 69373 Cedex 08

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

    Montpellier, 34295

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

    Paris, 75571

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

    Paris, 75935

  • CHRU de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67000

Other trials in France

United Kingdom5 sites
  • Local Institution - 0075

    Cambridge, Cambridgeshire, CB2 0QQ

  • Local Institution - 0074

    Liverpool, England, L12 2AP

  • Local Institution - 0054

    London, Londonderry, NW1 2PG

  • Local Institution - 0053

    London, SM2 5PT

  • Local Institution - 0068

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

Other trials in United Kingdom

Australia3 sites
  • Local Institution - 0042

    Nedlands, Western Australia, 6009

  • Local Institution - 0037

    Randwick, New South Wales, 2031

  • Royal Childrens Hospital RCH - Queensland Childrens Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Netherlands1 site
  • Princess Maxima Center for pediatric oncology

    Utrecht, 3584 CS

Other trials in Netherlands

About this study

Official title: 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

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.

Being tested
Relatlimab, Nivolumab
Keywords
Pediatric, Lymphoma, Non-Hodgkin, Hodgkin Disease, Relatlimab, Nivolumab, Lymphocyte Activation Gene-3, Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal B-cell Lymphoma, Lymphoma, Large-Cell, Anaplastic, Burkitt lymphoma, Lymphoblastic lymphoma, NK/ T-cell lymphoma, Peripheral T-cell lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Extranodal NK-T-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelatlimabDrug

    Also called BMS-986016

    Specified Dose on Specified Days

  • NivolumabDrug

    Also called BMS-936558

    Specified Dose on Specified Days

Study groups in NCT05255601
Study groupRoleWhat they receive
Relatlimab + NivolumabExperimentalNot described
Receives: Drug: Relatlimab; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

    Hepatic DLT

    • ALT or AST > 8 × ULN
    • ALT or AST > 5 and ≤ 8 × ULN, that fails to return to ≤ Grade 1 within 2 weeks despite medical intervention.
    • TB > 5 × ULN.
    • ALT or AST > 3 × ULN and concurrent total bilirubin > 2 × ULN. Non-Hematologic DLT
    • ≥ Grade 2 episcleritis, uveitis, iritis or any other immune-related eye pain or reduction in visual acuity that requires systemic treatment.
    • ≥ Grade 3 non-hepatic or non-hematologic toxicity with the exceptions noted below.

    Hematologic DLT

    • Grade 4 anemia not explained by underlying disease.
    • Grade 3 febrile neutropenia lasting > 48 hours, or Grade 4 febrile neutropenia
    • Grade 4 neutropenia that does not resolve to Grade 3 or less within 5 days of initiation of granulocyte colony stimulating factor.
    • Grade 3 thrombocytopenia associated with clinically significant bleeding.
    • Grade 3 hemolysis

    Measured: 1 cycle, defined as 28 days

  2. Complete Metabolic Response (CMR) Rate - Part B

    The CMR rate is defined as the percentage of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria.

    No participants enrolled in Part B.

    Measured: From first dose until the first documented response

  3. Number of Participants With Adverse Events (AEs) - Part A

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

    Measured: From first dose to 135 days post last dose (Up to approximately 11 months)

  4. Number of Participants Who Died - Part A

    Number of participants who died due to any cause

    Measured: from first dose to 135 days post last dose (Up to approximately 11 months)

  5. Number of Participants With Serious Adverse Events (SAEs) - Part A

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

    Measured: from first dose to 135 days post last dose (Up to approximately 11 months)

  6. Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

    Measured: From first dose to 135 days post last dose (Up to approximately 11 months)

  7. Number of Participants With Laboratory Abnormalities - Part A

    Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry.

    Grade 3=severe Grade 4=life-threatening Grade 5=death

    Measured: From first dose to 30 days post last dose (Up to approximately 8 months)

  8. Maximum Serum Concentration (Cmax)

    Maximum observed serum concentration of Analyte BMS-986016

    Measured: Cycle 1 Day 1

  9. Time to Maximum Concentration (Tmax)

    Time of maximum observed serum concentration of Analyte BMS-986016

    Measured: Cycle 1 Day 1

  10. Area Under the Concentration-time Curve [AUC(TAU)]

    Area Under the Concentration-time Curve [AUC(TAU)] for Analyte BMS-986016

    Measured: Cycle 1 Day 1

  11. Concentration Trough (Ctrough)

    Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558

    Measured: Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1

Secondary outcomes (6)
  1. Number of Participants With Adverse Events (AEs) - Part B

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

    No participants enrolled in part B.

    Measured: From first dose to 135 days post last dose

  2. Number of Participants With Serious Adverse Events (SAEs) - Part B

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

    No participants enrolled in part B.

    Measured: From first dose to 135 days post last dose

  3. Number of Participants With Adverse Events Leading to Discontinuation - Part B

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

    No participants enrolled in part B.

    Measured: From first dose to 135 days post last dose

  4. Number of Participants Who Died - Part B

    Number of participants who died due to any cause. No participants enrolled in part B.

    Measured: From first dose to 135 days post last dose

  5. Number of Participants With Laboratory Abnormalities - Part B

    No participants enrolled in part B.

    Measured: From first dose to 135 days post last dose

  6. Objective Response Rate (ORR) - Part B

    ORR is defined as the percentage of all response evaluable participants who achieve a best response of CMR or PMR using the Lugano 2014 classification.

    No participants enrolled in part B

    Measured: From to

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start13 Sep 2022
  3. Primary completion3 Dec 2025
  4. Study completion3 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05255601
Sponsor's protocol ID
CA224-069
Other IDs
2023-503715-14, U1111-1264-4062, 2023
Acronym
RELATIVITY-069
Status last verified
Jun 2026
First submitted
15 Feb 2022
Last updated
26 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Relatlimab and Nivolumab in people with Lymphoma, Non-Hodgkin and Hodgkin Disease, run by Bristol-Myers Squibb at 51 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Italy, Spain, France, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A (time frame: 1 cycle, defined as 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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