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

NCT05255601 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: CA224-0692023-503715-14U1111-1264-4062
• Study Type: interventional
• Target: 5
• Locations: 7 countries
• Sites: 51

Brief 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.

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

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

Outcome Measures

Primary Outcomes (11)

• 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

  1 cycle, defined as 28 days

• 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.

  From first dose until the first documented response

• 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.

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

• Number of Participants Who Died - Part A

  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

  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

  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

  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)

  Maximum observed serum concentration of Analyte BMS-986016

  Cycle 1 Day 1

• Time to Maximum Concentration (Tmax)

  Time of maximum observed serum concentration of Analyte BMS-986016

  Cycle 1 Day 1

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

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

  Cycle 1 Day 1

• Concentration Trough (Ctrough)

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

  Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1

Secondary Outcomes (6)

• Number of Participants With Adverse Events (AEs) - Part B

  From first dose to 135 days post last dose

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

  From first dose to 135 days post last dose

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

  From first dose to 135 days post last dose

• Number of Participants Who Died - Part B

  From first dose to 135 days post last dose

• Number of Participants With Laboratory Abnormalities - Part B

  From first dose to 135 days post last dose

Study Arms (1)

Relatlimab + Nivolumab

EXPERIMENTAL

Drug: Relatlimab; Drug: Nivolumab

Interventions

Relatlimab DRUG

Specified Dose on Specified Days

Also known as: BMS-986016

Relatlimab + Nivolumab

Nivolumab DRUG

Specified Dose on Specified Days

Also known as: BMS-936558

Relatlimab + Nivolumab

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (51)

Local Institution - 0077

Birmingham, Alabama, 35233, United States

Location

Local Institution - 0024

Phoenix, Arizona, 85016, United States

Location

Local Institution - 0035

Palo Alto, California, 94304, United States

Location

Local Institution - 0032

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0066

Fort Myers, Florida, 33908, United States

Location

Local Institution - 0073

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0025

Minneapolis, Minnesota, 55454, United States

Location

Local Institution - 0020

Jackson, Mississippi, 39216, United States

Location

Local Institution - 0071

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0060

New York, New York, 10032, United States

Location

Local Institution - 0059

Valhalla, New York, 10595, United States

Location

Local Institution - 0029

Austin, Texas, 78723, United States

Location

Local Institution - 0026

San Antonio, Texas, 78207, United States

Location

Local Institution - 0037

Randwick, New South Wales, 2031, Australia

Location

Royal Childrens Hospital RCH - Queensland Childrens Hospital

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0042

Nedlands, Western Australia, 6009, Australia

Location

CHU dAngers - Pole Pediatrie

Angers, Angers Cedex 9, 49933, France

Location

Groupe Hospitalier Pellegrin - Hopital des enfants

Bordeaux, 33076, France

Location

Local Institution - 0033

Caen, 14033, France

Location

Local Institution - 0067

La Tronche, 38700, France

Location

Institut d Hematologie et d Oncologie Pediatriques

Lyon, 69373 Cedex 08, France

Location

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

Montpellier, 34295, France

Location

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

Paris, 75571, France

Location

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

Paris, 75935, France

Location

CHRU de Strasbourg-Hopital de Hautepierre

Strasbourg, 67000, France

Location

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Milano, 20133, Italy

Location

Local Institution - 0010

Aviano, 33081, Italy

Location

Azienda Ospedaliero Universitaria di Bologna

Bologna, 40138, Italy

Location

Local Institution - 0040

Florence, 50139, Italy

Location

Local Institution - 0070

Milan, 20162, Italy

Location

Fondazione MBBM - Clinica Pediatrica

Monza, 20900, Italy

Location

Azienda Ospedale Universita Padova

Padova, 35128, Italy

Location

Local Institution - 0041

Pavia, 27100, Italy

Location

Local Institution - 0002

Roma, 00165, Italy

Location

Local Institution - 0004

Turin, 10126, Italy

Location

Princess Maxima Center for pediatric oncology

Utrecht, 3584 CS, Netherlands

Location

Local Institution - 0069

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Local Institution - 0030

Madrid, Madrid, 28009, Spain

Location

Local Institution - 0046

Barcelona, 08035, Spain

Location

Local Institution - 0058

Madrid, 28027, Spain

Location

Local Institution - 0044

Madrid, 28040, Spain

Location

Local Institution - 0055

Madrid, 28041, Spain

Location

Local Institution - 0045

Madrid, 28046, Spain

Location

Local Institution - 0062

Pamplona, 31008, Spain

Location

Local Institution - 0023

Seville, 41013, Spain

Location

Local Institution - 0049

Valencia, 46026, Spain

Location

Local Institution - 0075

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Local Institution - 0074

Liverpool, England, L12 2AP, United Kingdom

Location

Local Institution - 0054

London, Londonderry, NW1 2PG, United Kingdom

Location

Local Institution - 0068

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

Location

Local Institution - 0053

London, SM2 5PT, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

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

Interventions

relatlimab; Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, T-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: September 13, 2022
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2026-06

Locations

US (13); GB (5); NL (1); AU (3); IT (10); FR (9); ES (10)