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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

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NCT05255601 · results posted

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
5actual
Sites
51
Countries
Australia, France, Italy +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-09-13actualWhen the study began enrolling
Primary completion2025-12-03actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-12-03actualThe whole study's end, after follow-up
First posted2022-02-24actualWhen this record first appeared on the registry
Results posted2026-06-26actualWhen the sponsor posted results to the registry
Record updated2026-06-26actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease

Interventions

  • Drug: Relatlimab — also filed as BMS-986016
  • Drug: Nivolumab — also filed as BMS-936558

Primary outcomes

what the primary-completion date above is the date OF
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
measured 1 cycle, defined as 28 days
Complete Metabolic Response (CMR) Rate - Part B
measured From first dose until the first documented response
Number of Participants With Adverse Events (AEs) - Part A
measured From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants Who Died - Part A
measured from first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
measured from first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A
measured From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Laboratory Abnormalities - Part A
measured From first dose to 30 days post last dose (Up to approximately 8 months)
Maximum Serum Concentration (Cmax)
measured Cycle 1 Day 1
Time to Maximum Concentration (Tmax)
measured Cycle 1 Day 1
Area Under the Concentration-time Curve [AUC(TAU)]
measured Cycle 1 Day 1
Concentration Trough (Ctrough)
measured Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1

Posted documents

hosted by the registry — we link, never re-serve
Study Protocol and Statistical Analysis Planposted 2024-08-19 · 28.8 MB · Prot_SAP_000.pdf

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