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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, Non-Hodgkin, Hodgkin Disease

Intervention / Treatment
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* Drug: Relatlimab
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relatlimab + Nivolumab<br> | Drug: Relatlimab<br>* Specified Dose on Specified Days<br>* Other names: BMS-986016;Drug: Nivolumab<br>* Specified Dose on Specified Days<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities (DLTs) |  | Up to 135 days following last dose | 
| Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D) |  | Up to 135 days following last dose | 
| Number of participants with Adverse Events (AEs) |  | Up to 135 days following last dose | 
| Number of participants with serious adverse events (SAEs) |  | Up to 135 days following last dose | 
| Number of participants with AEs leading to discontinuation |  | Up to 135 days following last dose | 
| Number of deaths |  | Up to 135 days following last dose | 
| Number of participants with clinical laboratory abnormalities |  | Up to 135 days following last dose | 
| Maximum observed plasma concentration (Cmax) |  | Up to 96 weeks | 
| Trough observed concentration (Ctrough) |  | Up to 96 weeks | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 96 weeks | 
| Area Under the Curve within a dosing interval (AUC(TAU)) |  | Up to 96 weeks | 
| Complete Metabolic Response (CMR) Rate defined as the proportion of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria |  | Up to 2 years from the last treatment of last participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with AEs |  | Up to 135 days following last dose | 
| Number of participants with SAEs |  | Up to 135 days following last dose | 
| Number of participants with AEs leading to discontinuation |  | Up to 135 days following last dose | 
| Number of deaths |  | Up to 135 days following last dose | 
| Number of participants with clinical laboratory abnormalities |  | Up to 135 days following last dose | 
| Overall Response Rate (ORR) defined as the proportion of all response- evaluable participants who achieve a best response of CMR or partial metabolic response (PMR) using the Lugano 2014 classification |  | Up to 2 years from the last treatment of last participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Lymphoma, Non-Hodgkin, Hodgkin Disease, Relatlimab, Nivolumab, Lymphocyte Activation Gene-3, Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal B-cell Lymphoma, Lymphoma, Large-Cell, Anaplastic