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NCT05255601 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05255601: Clinical Trial Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT05255601 is a Phase 1 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05255601, a Phase 1 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Hepatic DLT * ALT or AST \> 8 × ULN * ALT or AST \> 5 and ≤ 8 × ULN, that fails to return to ≤ Grade 1 within 2 weeks despite medical intervention. * TB \> 5 × ULN. * ALT or AST \> 3 × ULN and concurrent total bilirubin \> 2 × ULN. Non-Hematologic DLT * ≥ Grade 2 episcleritis, uveitis, iritis or any other immune-related eye pain or reduction in visual acuity that requires systemic treatment. * ≥ Grade 3 non-hepatic or non-hematologic toxicity with the exceptions noted below. Hematologic DLT *
Interventions
- DRUG Nivolumab
- DRUG Relatlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2025-12-03 |
| Phase | Phase 1 |
Why NCT05255601 stopped before completion
NCT05255601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT05255601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05255601 about?
NCT05255601 is a clinical study 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 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.
What is the current status of trial NCT05255601?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-09-13. Estimated completion is 2025-12-03.
What interventions are being tested in trial NCT05255601?
The interventions under investigation include: Nivolumab (DRUG), Relatlimab (DRUG).
Who is sponsoring clinical trial NCT05255601?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05255601's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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