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 (RELATIVITY-069)

June 2, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Local Institution - 0037
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Royal Childrens Hospital RCH - Queensland Childrens Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0042
  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital des Enfants
      • Caen, France, 14033
        • Local Institution - 0033
      • La Tronche, France, 38700
        • Local Institution - 0067
      • Lyon, France, 69373 Cedex 08
        • Institut d Hematologie et d Oncologie Pediatriques
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve
      • Paris, France, 75571
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau
      • Paris, France, 75935
        • Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre
      • Strasbourg, France, 67000
        • CHRU de Strasbourg-Hopital de Hautepierre
    • Angers Cedex 9
      • Angers, Angers Cedex 9, France, 49933
        • CHU dAngers - Pole Pediatrie
  • Italy
      • Aviano, Italy, 33081
        • Local Institution - 0010
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria di Bologna
      • Florence, Italy, 50139
        • Local Institution - 0040
      • Milan, Italy, 20162
        • Local Institution - 0070
      • Monza, Italy, 20900
        • Fondazione MBBM - Clinica Pediatrica
      • Padova, Italy, 35128
        • Azienda Ospedale Universita Padova
      • Pavia, Italy, 27100
        • Local Institution - 0041
      • Roma, Italy, 00165
        • Local Institution - 0002
      • Turin, Italy, 10126
        • Local Institution - 0004
    • Milano
      • Milan, Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale Dei Tumori
  • Netherlands
      • Utrecht, Netherlands, 3584 CS
        • Princess Máxima Center for Pediatric Oncology
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0046
      • Madrid, Spain, 28041
        • Local Institution - 0055
      • Madrid, Spain, 28027
        • Local Institution - 0058
      • Madrid, Spain, 28040
        • Local Institution - 0044
      • Madrid, Spain, 28046
        • Local Institution - 0045
      • Pamplona, Spain, 31008
        • Local Institution - 0062
      • Seville, Spain, 41013
        • Local Institution - 0023
      • Valencia, Spain, 46026
        • Local Institution - 0049
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Local Institution - 0069
    • Madrid
      • Madrid, Madrid, Spain, 28009
        • Local Institution - 0030
  • United Kingdom
      • London, United Kingdom, SM2 5PT
        • Local Institution - 0053
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Local Institution - 0075
    • England
      • Liverpool, England, United Kingdom, L12 2AP
        • Local Institution - 0074
    • Londonderry
      • London, Londonderry, United Kingdom, NW1 2PG
        • Local Institution - 0054
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
        • Local Institution - 0068
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Local Institution - 0077
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Local Institution - 0024
    • California
      • Palo Alto, California, United States, 94304
        • Local Institution - 0035
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Local Institution - 0032
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Local Institution - 0066
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0073
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Local Institution - 0025
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Local Institution - 0020
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0071
    • New York
      • New York, New York, United States, 10032
        • Local Institution - 0060
      • Valhalla, New York, United States, 10595
        • Local Institution - 0059
    • Texas
      • Austin, Texas, United States, 78723
        • Local Institution - 0029
      • San Antonio, Texas, United States, 78207
        • Local Institution - 0026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relatlimab + Nivolumab
Drug: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
Drug: Relatlimab
Specified Dose on Specified Days
Other Names:
  • BMS-986016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Time Frame: 1 cycle, defined as 28 days

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
1 cycle, defined as 28 days
Complete Metabolic Response (CMR) Rate - Part B
Time Frame: From first dose until the first documented response

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.
From first dose until the first documented response
Number of Participants With Adverse Events (AEs) - Part A
Time Frame: From first dose to 135 days post last dose (Up to approximately 11 months)
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.
From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants Who Died - Part A
Time Frame: from first dose to 135 days post last dose (Up to approximately 11 months)
Number of participants who died due to any cause
from first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
Time Frame: from first dose to 135 days post last dose (Up to approximately 11 months)
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.
from first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A
Time Frame: From first dose to 135 days post last dose (Up to approximately 11 months)
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.
From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Laboratory Abnormalities - Part A
Time Frame: From first dose to 30 days post last dose (Up to approximately 8 months)

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

Grade 3=severe Grade 4=life-threatening Grade 5=death
From first dose to 30 days post last dose (Up to approximately 8 months)
Maximum Serum Concentration (Cmax)
Time Frame: Cycle 1 Day 1
Maximum observed serum concentration of Analyte BMS-986016
Cycle 1 Day 1
Time to Maximum Concentration (Tmax)
Time Frame: Cycle 1 Day 1
Time of maximum observed serum concentration of Analyte BMS-986016
Cycle 1 Day 1
Area Under the Concentration-time Curve [AUC(TAU)]
Time Frame: Cycle 1 Day 1
Area Under the Concentration-time Curve [AUC(TAU)] for Analyte BMS-986016
Cycle 1 Day 1
Concentration Trough (Ctrough)
Time Frame: Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1
Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558
Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) - Part B
Time Frame: From first dose to 135 days post last dose

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.
From first dose to 135 days post last dose
Number of Participants With Serious Adverse Events (SAEs) - Part B
Time Frame: From first dose to 135 days post last dose

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.
From first dose to 135 days post last dose
Number of Participants With Adverse Events Leading to Discontinuation - Part B
Time Frame: From first dose to 135 days post last dose

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.
From first dose to 135 days post last dose
Number of Participants Who Died - Part B
Time Frame: From first dose to 135 days post last dose
Number of participants who died due to any cause. No participants enrolled in part B.
From first dose to 135 days post last dose
Number of Participants With Laboratory Abnormalities - Part B
Time Frame: From first dose to 135 days post last dose
No participants enrolled in part B.
From first dose to 135 days post last dose
Objective Response Rate (ORR) - Part B
Time Frame: From to

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
From to

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

December 3, 2025

Study Completion (Actual)

December 3, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-069
  • U1111-1264-4062 (Registry Identifier: WHO)
  • 2023-503715-14 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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