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
Recipient organisationNIHR Cambridge Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Dec 2027
In plain English
AI plain-English summary
A clinical trial is testing whether combining two immunotherapy drugs—relatlimab and nivolumab—can safely shrink tumours in children and young adults whose lymphoma has returned or stopped responding to treatment. Non-Hodgkin lymphoma accounts for 10% to 12% of childhood cancers. While initial treatment is often successful, patients whose disease relapses or resists therapy have poor outcomes and no standard treatment approach. This trial directly addresses that gap by evaluating a drug combination already used in adults, but not yet tested in younger patients. If the combination proves safe and effective, it could offer a new, targeted treatment option for a group that currently has few alternatives. The trial has two parts: Part A tests different doses for safety in up to 10 participants aged 0 to 18; Part B tests the chosen dose for efficacy in up to 66 participants aged 0 to 30. The study runs across about 50 hospitals in 7 countries and is expected to last roughly 5 years. Success would mean a consistent, evidence-based therapy for children and young adults with hard-to-treat lymphomas.
View original technical description
The purpose of conducting this clinical trial is to learn more about the safety and effectiveness of relatlimab and nivolumab. In the treatment of Recurrent or Refractory Classical Hodgkin Lymphoma (CHL) and Non-Hodgkin Lymphoma (NHL).NHL is third in the list of most common childhood cancers constituting 10% to 12% of cancers in children. Although the outcome for NHL at diagnosis is favourable using treatment strategies that are tailored to the specific patient and disease, those with recurrent or refractory disease do not do well. Treatment is not consistent in their approach and there is no recommendation on the best approach.There are 2 parts to this study. In Part A, different doses of relatlimab and nivolumab will be given together to learn more about the safety of the study drug combination in participants with cHL and NHL. In Part B, participants will receive nivolumab and relatlimab at the dose that was chosen from Part A. Part B will look at how effective the study drug combination is in participants with recurrent/relapsed or refractory cHL and NHL participating.The study is divided into 3 periods: a screening period, a treatment period, and a follow-up period.The clinical trial will be conducted in approximately 50 centres in 7 countries with at least 10 children and young adults with recurrent/relapsed or refractory cHL and NHL participating in Part A and up to 66 participants with recurrent/relapsed or refractory cHL and NHL participating in Part B. The age range of participants in part A of this trial are from 0 to 18 and for Part b 0-30.The clinical trial will be conducting in hospitals.The expected duration of the trial is expected to be approximately 5 years
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