NCT05255601 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2026-06-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Events (AEs) - Part B

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outcome · POSTED

Number of Participants With Serious Adverse Events (SAEs) - Part B

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outcome · POSTED

Number of Participants With Adverse Events Leading to Discontinuation - Part B

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outcome · POSTED

Number of Participants Who Died - Part B

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outcome · POSTED

Number of Participants With Laboratory Abnormalities - Part B

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outcome · POSTED

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

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outcome · POSTED

Complete Metabolic Response (CMR) Rate - Part B

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outcome · POSTED

Objective Response Rate (ORR) - Part B

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outcome · POSTED

Number of Participants With Adverse Events (AEs) - Part A

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outcome · POSTED

Number of Participants Who Died - Part A

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outcome · POSTED

Number of Participants With Serious Adverse Events (SAEs) - Part A

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outcome · POSTED

Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A

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outcome · POSTED

Number of Participants With Laboratory Abnormalities - Part A

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outcome · POSTED

Maximum Serum Concentration (Cmax)

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outcome · POSTED

Time to Maximum Concentration (Tmax)

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outcome · POSTED

Area Under the Concentration-time Curve [AUC(TAU)]

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outcome · POSTED

Concentration Trough (Ctrough)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1or more lines of standard therapy. * Participants with pathologically confirmed R/R NHL after non-response to or failure of 1or more lines of standard therapy, including, but not limited to, R/R 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 with pathologically confirmed R/R NHL after non-response to or failure of 2 or more lines of standard therapy, including Burkitt lymphoma (blast count \<25% malignant Burkitt cells and/or per the investigator's clinical assessment of risk status), lymphoblastic lymphoma (blast count \< 25% of marrow nucleated cells and/or per the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype). * The participant's current disease state must be R/R to standard therapy. * Participants must have measurable PET positive disease in both cHL and NHL cohorts. Exclusion Criteria: * 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. * Participants with clinically significant systemic illnesses unrelated to the cancer as judged by the investigators, which would compromise the participant's ability to tolerate the study treatment. * Participants with autoimmune disease. * Prior allogeneic bone marrow transplantation. Other protocol-defined inclusion/exclusion criteria apply
healthy Volunteers: false
maximum Age: 30 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Relatlimab
Drug: Nivolumab
label
Relatlimab + Nivolumab
type
EXPERIMENTAL

interventions

arm Group Labels
Relatlimab + Nivolumab
description
Specified Dose on Specified Days
name
Relatlimab
other Names
BMS-986016
type
DRUG
arm Group Labels
Relatlimab + Nivolumab
description
Specified Dose on Specified Days
name
Nivolumab
other Names
BMS-936558
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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 * Grade 4 anemia not explained by underlying disease. * Grade 3 febrile neutropenia lasting \> 48 hours, or Grade 4 febrile neutropenia * Grade 4 neutropenia that does not resolve to Grade 3 or less within 5 days of initiation of granulocyte colony stimulating factor. * Grade 3 thrombocytopenia associated with clinically significant bleeding. * Grade 3 hemolysis
measure
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
time Frame
1 cycle, defined as 28 days
description
The CMR rate is defined as the percentage of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria. No participants enrolled in Part B.
measure
Complete Metabolic Response (CMR) Rate - Part B
time Frame
From first dose until the first documented response
description
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
measure
Number of Participants With Adverse Events (AEs) - Part A
time Frame
From first dose to 135 days post last dose (Up to approximately 11 months)
description
Number of participants who died due to any cause
measure
Number of Participants Who Died - Part A
time Frame
from first dose to 135 days post last dose (Up to approximately 11 months)
description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
measure
Number of Participants With Serious Adverse Events (SAEs) - Part A
time Frame
from first dose to 135 days post last dose (Up to approximately 11 months)
description
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
measure
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A
time Frame
From first dose to 135 days post last dose (Up to approximately 11 months)
description
Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry. Grade 3=severe Grade 4=life-threatening Grade 5=death
measure
Number of Participants With Laboratory Abnormalities - Part A
time Frame
From first dose to 30 days post last dose (Up to approximately 8 months)
description
Maximum observed serum concentration of Analyte BMS-986016
measure
Maximum Serum Concentration (Cmax)
time Frame
Cycle 1 Day 1
description
Time of maximum observed serum concentration of Analyte BMS-986016
measure
Time to Maximum Concentration (Tmax)
time Frame
Cycle 1 Day 1
description
Area Under the Concentration-time Curve \[AUC(TAU)\] for Analyte BMS-986016
measure
Area Under the Concentration-time Curve [AUC(TAU)]
time Frame
Cycle 1 Day 1
description
Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558
measure
Concentration Trough (Ctrough)
time Frame
Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1

secondary Outcomes

description
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. No participants enrolled in part B.
measure
Number of Participants With Adverse Events (AEs) - Part B
time Frame
From first dose to 135 days post last dose
description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. No participants enrolled in part B.
measure
Number of Participants With Serious Adverse Events (SAEs) - Part B
time Frame
From first dose to 135 days post last dose
description
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. No participants enrolled in part B.
measure
Number of Participants With Adverse Events Leading to Discontinuation - Part B
time Frame
From first dose to 135 days post last dose
description
Number of participants who died due to any cause. No participants enrolled in part B.
measure
Number of Participants Who Died - Part B
time Frame
From first dose to 135 days post last dose
description
No participants enrolled in part B.
measure
Number of Participants With Laboratory Abnormalities - Part B
time Frame
From first dose to 135 days post last dose
description
ORR is defined as the percentage of all response evaluable participants who achieve a best response of CMR or PMR using the Lugano 2014 classification. No participants enrolled in part B
measure
Objective Response Rate (ORR) - Part B
time Frame
From to

Full study description

brief 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.

Source references