Overview

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

Status:
Not yet recruiting
Trial end date:
2030-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Nivolumab
Criteria
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 high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)

- Pathologically confirmed high-risk, R/R non-Hodgkin lymphoma (NHL) after failure or
non-response to first-line therapy, including but not limited to diffuse large B-cell
lymphoma (DLBCL), anaplastic large cell lymphoma (ALCL) and primary mediastinal B-cell
lymphoma

- Pathologically confirmed recurrent cHL or NHL

- Must have measurable [18F]fluorodeoxyglucose-positron emission tomography-computed
tomography (FDG-PET-CT) 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

- Prior autologous stem cell transplantation (HDCT/ASCT)

- History of allogeneic bone marrow transplantation and with active graft versus host
disease (GVHD) and prior history of Grade > 2 GVHD

Other protocol-defined inclusion/exclusion criteria apply