Results from a Phase 1/2 trial evaluating nivolumab and relatlimab for Hodgkin and non-Hodgkin lymphoma in pediatric and young adult participants were posted on 2026-06-26. The study was terminated and reported zero dose-limiting toxicities across both flat-dosing and age/weight-based dosing arms.
Background
The trial investigated the combination of relatlimab and nivolumab for recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma in pediatric and young adult participants.
Trial design
This was a Phase 1/2 trial (NCT05255601) titled "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". The study enrolled 5 participants with Hodgkin Disease and Non-Hodgkin Lymphoma. The trial was terminated.
Key results
The trial reported key safety measurements for participants in Part A:
- For the Flat Dosing (AF) group, the Number of Participants With Dose-Limiting Toxicities (DLTs) was 0 Participants.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants With Dose-Limiting Toxicities (DLTs) was 0 Participants.
- For the Flat Dosing (AF) group, the Number of Participants With Adverse Events (AEs) was 4 Participants.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants With Adverse Events (AEs) was 1 Participant.
- For the Flat Dosing (AF) group, the Number of Participants Who Died was 0 Participants.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants Who Died was 1 Participant.
- For the Flat Dosing (AF) group, the Number of Participants With Serious Adverse Events (SAEs) was 1 Participant.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants With Serious Adverse Events (SAEs) was 1 Participant.
- For the Flat Dosing (AF) group, the Number of Participants With Adverse Events (AEs) Leading to Discontinuation was 0 Participants.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants With Adverse Events (AEs) Leading to Discontinuation was 0 Participants.
- For the Flat Dosing (AF) group, the Number of Participants With Laboratory Abnormalities was 1 Participant.
- For the Age/Weight-based Dosing (AW) group, the Number of Participants With Laboratory Abnormalities was 0 Participants.
What this means
The posted results from this terminated Phase 1/2 study indicate that the combination of relatlimab and nivolumab in pediatric and young adult participants with lymphoma showed no dose-limiting toxicities in either dosing arm. While 4 participants in the flat-dosing group and 1 in the age/weight-based dosing group experienced adverse events, and 1 participant in each group experienced serious adverse events, the absence of DLTs suggests a manageable safety profile within the small enrolled population. One death was reported in the age/weight-based dosing group.
Source
The trial results were posted on 2026-06-26 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT05255601.