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)

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Hodgkin Disease

Lymphoma, Non-Hodgkin

Treatments

Drug: Relatlimab

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05255601

2021-000493-29 (EudraCT Number)

CA224-069

U1111-1264-4062 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
Participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to 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 must have measurable PET positive disease in both cHL and NHL cohorts.

Exclusion criteria

Aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia.
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
Prior autologous stem cell transplantation (HDCT/ASCT)
History of allogeneic bone marrow transplantation.

Other protocol-defined inclusion/exclusion criteria apply