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
Launched by BRISTOL-MYERS SQUIBB · Feb 15, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment combination called relatlimab and nivolumab for children and young adults with certain types of lymphoma, specifically classical Hodgkin lymphoma and non-Hodgkin lymphoma, that has not responded to previous therapies. The main goals of the study are to check how safe the treatment is, how well it works, and the levels of the drugs in the body. The trial is currently looking for participants who have been diagnosed with high-risk lymphoma that has returned or did not improve after at least one other treatment.
To be eligible for this study, participants must be diagnosed with specific types of lymphoma and show measurable signs of the disease on imaging tests. Key exclusions include those with certain types of brain lymphoma or previous treatments that target specific immune pathways. Participants can expect to receive close monitoring throughout the trial, and they may benefit from a new treatment option. It's important for patients and families to discuss this opportunity with their healthcare team to see if it might be the right fit.
Gender
ALL
Eligibility criteria
- 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
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
West Palm Beach, Florida, United States
New York, New York, United States
Bronx, New York, United States
Valhalla, New York, United States
Jackson, Mississippi, United States
Madrid, , Spain
Madrid, , Spain
Nashville, Tennessee, United States
Fort Myers, Florida, United States
New Haven, Connecticut, United States
Valencia, , Spain
Milano, , Italy
Bordeaux, , France
Berlin, , Germany
Santander, , Spain
Napoli, , Italy
Bologna, , Italy
Hershey, Pennsylvania, United States
Phoenix, Arizona, United States
Bologna, , Italy
Aachen, , Germany
Paris, , France
Sevilla, , Spain
Pavia, , Italy
Montpellier, , France
Madrid, , Spain
Nedlands, Western Australia, Australia
Madrid, , Spain
Muenster, , Germany
Pamplona, Navarra, Spain
Cambridge, , United Kingdom
London, , United Kingdom
Barcelona, , Spain
Valencia, , Spain
Sutton, , United Kingdom
Monza, , Italy
Orlando, Florida, United States
Florence, , Italy
Saint Louis, Missouri, United States
Nottingham, , United Kingdom
Strasbourg, , France
Jackson, Mississippi, United States
Utrecht, , Netherlands
Orlando, Florida, United States
Barcelona, , Spain
Nashville, Tennessee, United States
Madrid, Other, Spain
Utrecht, , Netherlands
Madrid, , Spain
Monza, , Italy
Padova, , Italy
Newcastle Upon Tyne, Other, United Kingdom
Madrid, , Spain
Madrid, Other, Spain
Nedlands, Western Australia, Australia
Bordeaux, , France
Munich, , Germany
West Palm Beach, Florida, United States
Minneapolis, Minnesota, United States
Bronx, New York, United States
Valhalla, New York, United States
Austin, Texas, United States
San Antonio, Texas, United States
Lyon, , France
Rennes, , France
Giessen, , Germany
Aviano, , Italy
Florence, , Italy
Genoa, , Italy
Roma, , Italy
Turin, , Italy
Barcelona, , Spain
Birmingham, , United Kingdom
Bristol, , United Kingdom
Wilmington, Delaware, United States
New York, New York, United States
Randwick, New South Wales, Australia
Paris, , France
Madrid, , Spain
Bristol, Somerset, United Kingdom
Wilmington, Delaware, United States
Angers, , France
Bologna, , Italy
South Brisbane, Queensland, Australia
Birmingham, West Midlands, United Kingdom
Padova, , Italy
Phoenix, Arizona, United States
Palo Alto, California, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Valhalla, New York, United States
Hershey, Pennsylvania, United States
Austin, Texas, United States
San Antonio, Texas, United States
Caen, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Paris, , France
Strasbourg, , France
Pavia, Pv, Italy
Aviano, , Italy
Florence, , Italy
Genoa, , Italy
Monza, , Italy
Napoli, , Italy
Roma, , Italy
Turin, , Italy
Utrecht, , Netherlands
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
London, Londonderry, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Sutton, Surrey, United Kingdom
Saint Louis, Missouri, United States
Fort Myers, Florida, United States
Angers, Angers Cedex 9, France
La Tronche, , France
Milan, , Italy
Esplugues De Llobregat, , Spain
Newcastle Upon Tyne, , United Kingdom
Hackensack, New Jersey, United States
Nimes, , France
Madison, Wisconsin, United States
Nedlands, Western Australia, Australia
Aachen, , Germany
Berlin, , Germany
Giessen, , Germany
Hamburg, , Germany
Muenster, , Germany
Munich, , Germany
Milano, , Italy
Pamplona, Navarra, Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Sevilla, , Spain
Sevilla, , Spain
Valencia, , Spain
Baltimore, Maryland, United States
San Antonio, Texas, United States
Milano, Other, Italy
Palo Alto, California, United States
La Tronche, , France
Strasbourg, , France
Esplugues De Llobregat, , Spain
Paris, , France
Liverpool, England, United Kingdom
Roma, , Italy
Perth, Western Australia, Australia
Roma, , Italy
Cambridge, , United Kingdom
Wilmington, Delaware, United States
Turin, , Italy
Lyon, , France
Sevilla, , Spain
London, Londonderry, United Kingdom
London, Surrey, United Kingdom
Randwick, New South Wales, Australia
Liverpool, England, United Kingdom
Bordeaux, , France
Cambridge, Cambridgeshire, United Kingdom
Bronx, New York, United States
Hershey, Pennsylvania, United States
Nashville, Tennessee, United States
London, , United Kingdom
Birmingham, Alabama, United States
Norfolk, Virginia, United States
Milano, Lombardy, Italy
Orlando, Florida, United States
Austin, Texas, United States
South Brisbane, Queensland, Australia
Angers, Angers Cedex 9, France
Montpellier, , France
Paris, , France
Pavia, , Italy
Roma, , Italy
Esplugues De Llobregat, Barcelona, Spain
Newcastle Upon Tyne, Chelsea, United Kingdom
Angers, , France
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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