Relatlimab + Nivolumab in Pediatric and Young Adult Lymphomas (RELATIVITY-069)

Trial details

Who runs it

Bristol Myers Squibb International Corporation

Trial code

EU 2023-503715-14-00

Record updated

2025. december 16.

Original description

Part A: To characterize the safety, tolerability, and define the MTD or RP2D for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part A: To characterize the PK of relatlimab for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part B: To assess the preliminary efficacy of relatlimab + nivolumab based on the RP2D from part A in participants less than or equal to 30 years old with cHL (Cohort 1).Read full original descriptionShow less

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

Part A: To characterize the safety, tolerability, and define the MTD or RP2D for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part A: To characterize the PK of relatlimab for the combination of relatlimab + nivolumab in pediatric participants less than 18 years of age with R/R cHL and NHL. Part B: To assess the preliminary efficacy of relatlimab + nivolumab based on the RP2D from part A in participants less than or equal to 30 years old with cHL (Cohort 1).

Inclusion: Male and female participants less than 18 years of age (Part A), and less than or equal to 30 years of age (Part B) with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Cohort 1) and Non Hodgkin Lymphoma (NHL) (Cohort 2); Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1 or more lines of standard therapy; Participants with pathologically confirmed R/R NHL after non-response to or failure of 1 or 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); 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; 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).

Exclusion: Prior treatment with LAG-3-targeted agents; Participants with a history of allogeneic bone marrow transplantation; 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 treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies; 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; Participants who are pregnant or breastfeeding.

EU CTIS 2023-503715-14-00