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
NCT ID: NCT05255601
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2022-09-13
2028-07-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Relatlimab + Nivolumab
Relatlimab
Specified Dose on Specified Days
Nivolumab
Specified Dose on Specified Days
Interventions
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Relatlimab
Specified Dose on Specified Days
Nivolumab
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0077
Birmingham, Alabama, United States
Local Institution - 0024
Phoenix, Arizona, United States
Local Institution - 0035
Palo Alto, California, United States
Local Institution - 0032
New Haven, Connecticut, United States
Local Institution - 0061
Wilmington, Delaware, United States
Local Institution - 0066
Fort Myers, Florida, United States
Local Institution - 0017
Orlando, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Local Institution - 0073
Baltimore, Maryland, United States
Local Institution - 0025
Minneapolis, Minnesota, United States
Local Institution - 0020
Jackson, Mississippi, United States
Local Institution - 0012
St Louis, Missouri, United States
Local Institution - 0071
Hackensack, New Jersey, United States
Local Institution - 0060
New York, New York, United States
Local Institution - 0016
The Bronx, New York, United States
Local Institution - 0059
Valhalla, New York, United States
Local Institution - 0019
Hershey, Pennsylvania, United States
Local Institution - 0014
Nashville, Tennessee, United States
Local Institution - 0029
Austin, Texas, United States
Local Institution - 0026
San Antonio, Texas, United States
Local Institution - 0076
Norfolk, Virginia, United States
UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic
Madison, Wisconsin, United States
Local Institution - 0037
Randwick, New South Wales, Australia
Royal Childrens Hospital RCH - Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Local Institution - 0042
Nedlands, Western Australia, Australia
CHU dAngers - Pole Pediatrie
Angers, Angers Cedex 9, France
Groupe Hospitalier Pellegrin - Hopital des enfants
Bordeaux, , France
Local Institution - 0033
Caen, , France
Local Institution - 0067
La Tronche, , France
Institut d Hematologie et d Oncologie Pediatriques
Lyon, , France
Local Institution - 0034
Marseille, , France
Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve
Montpellier, , France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau
Paris, , France
Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre
Paris, , France
Local Institution - 0022
Rennes, , France
CHRU de Strasbourg-Hopital de Hautepierre
Strasbourg, , France
Local Institution - 0056
Aachen, , Germany
Local Institution - 0015
Berlin, , Germany
Local Institution - 0028
Giessen, , Germany
Local Institution - 0036
Hamburg, , Germany
Local Institution - 0051
Munich, , Germany
Local Institution - 0008
Münster, , Germany
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Milano, Italy
Local Institution - 0010
Aviano, , Italy
Azienda Ospedaliero Universitaria di Bologna
Bologna, , Italy
Local Institution - 0040
Florence, , Italy
Local Institution - 0005
Genoa, , Italy
Local Institution - 0070
Milan, , Italy
Fondazione MBBM - Clinica Pediatrica
Monza, , Italy
Local Institution - 0013
Napoli, , Italy
Azienda Ospedale Universita Padova
Padua, , Italy
Local Institution - 0041
Pavia, , Italy
Local Institution - 0002
Roma, , Italy
Local Institution - 0004
Turin, , Italy
Princess Maxima Center for pediatric oncology
Utrecht, , Netherlands
Local Institution - 0069
Esplugues de Llobregat, Barcelona, Spain
Local Institution - 0046
Barcelona, , Spain
Local Institution - 0009
Barcelona, , Spain
Local Institution - 0030
Madrid, , Spain
Local Institution - 0058
Madrid, , Spain
Local Institution - 0044
Madrid, , Spain
Local Institution - 0055
Madrid, , Spain
Local Institution - 0045
Madrid, , Spain
Local Institution - 0062
Pamplona, , Spain
Local Institution - 0011
Santander, , Spain
Local Institution - 0038
Seville, , Spain
Local Institution - 0023
Seville, , Spain
Local Institution - 0049
Valencia, , Spain
Local Institution - 0075
Cambridge, Cambridgeshire, United Kingdom
Local Institution - 0074
Liverpool, England, United Kingdom
Local Institution - 0054
London, Londonderry, United Kingdom
Local Institution - 0003
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0050
Bristol, Somerset, United Kingdom
Local Institution - 0068
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution - 0031
Birmingham, West Midlands, United Kingdom
Local Institution - 0053
London, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0077
Role: primary
Site 0029
Role: primary
Morag Whyte, Site 0039
Role: primary
Isabelle Pellier, Site 0063
Role: primary
Stephane Ducassou, Site 0048
Role: primary
Site 0033
Role: primary
Antony Ceraulo, Site 0021
Role: primary
Stephanie Haouy, Site 0018
Role: primary
Judith Landman Parker, Site 0006
Role: primary
Thierry Leblanc, Site 0047
Role: primary
Catherine Paillard, Site 0052
Role: primary
ELISABETTA SCHIAVELLO, Site 0001
Role: primary
Site 0010
Role: primary
Arcangelo Prete, Site 0007
Role: primary
Site 0070
Role: primary
Alessandra Sala, Site 0043
Role: primary
Marta Pillon, Site 0065
Role: primary
Site 0041
Role: primary
Auke Beishuizen, Site 0057
Role: primary
Site 0044
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-503715-14
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1264-4062
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA224-069
Identifier Type: -
Identifier Source: org_study_id