A Phase 1/2 interventional study of Relatlimab and Nivolumab in Lymphoma, Non-Hodgkin and Hodgkin Disease, sponsored by Bristol-Myers Squibb. Terminated at 51 sites in 7 countries. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
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.
1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.
This study's enrollment of 5 is below the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Drug: Relatlimab · Drug: Nivolumab
Specified Dose on Specified Days
Also known as: BMS-986016
Specified Dose on Specified Days
Also known as: BMS-936558
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
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
Time frame: 1 cycle, defined as 28 days
Complete Metabolic Response (CMR) Rate - Part B
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.
Time frame: From first dose until the first documented response
Number of Participants With Adverse Events (AEs) - Part A
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.
Time frame: From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants Who Died - Part A
Number of participants who died due to any cause
Time frame: from first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
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.
Time frame: 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
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.
Time frame: From first dose to 135 days post last dose (Up to approximately 11 months)
Number of Participants With Laboratory Abnormalities - Part A
Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry. Grade 3=severe Grade 4=life-threatening Grade 5=death
Time frame: From first dose to 30 days post last dose (Up to approximately 8 months)
Maximum Serum Concentration (Cmax)
Maximum observed serum concentration of Analyte BMS-986016
Time frame: Cycle 1 Day 1
Time to Maximum Concentration (Tmax)
Time of maximum observed serum concentration of Analyte BMS-986016
Time frame: Cycle 1 Day 1
Area Under the Concentration-time Curve [AUC(TAU)]
Area Under the Concentration-time Curve \[AUC(TAU)\] for Analyte BMS-986016
Time frame: Cycle 1 Day 1
Concentration Trough (Ctrough)
Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558
Time frame: Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1
Number of Participants With Adverse Events (AEs) - Part B
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.
Time frame: From first dose to 135 days post last dose
Number of Participants With Serious Adverse Events (SAEs) - Part B
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.
Time frame: From first dose to 135 days post last dose
Number of Participants With Adverse Events Leading to Discontinuation - Part B
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.
Time frame: From first dose to 135 days post last dose
Number of Participants Who Died - Part B
Number of participants who died due to any cause. No participants enrolled in part B.
Time frame: From first dose to 135 days post last dose
Number of Participants With Laboratory Abnormalities - Part B
No participants enrolled in part B.
Time frame: From first dose to 135 days post last dose
Objective Response Rate (ORR) - Part B
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
Time frame: From to
| Milestone | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Started | 4 | 1 |
| Completed | 0 | 0 |
| Not completed | 4 | 1 |
| Withdrew: Other reasons | 1 | 0 |
| Withdrew: Maximum clinical benefit | 1 | 0 |
| Withdrew: Disease progression | 2 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Number of participants who died due to any cause. No participants enrolled in part B.
No measurements were reported for this outcome.
No participants enrolled in part B.
No measurements were reported for this 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 * 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
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A | 0 | 0 |
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Number of Participants With Adverse Events (AEs) - Part A | 4 | 1 |
Number of participants who died due to any cause
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Number of Participants Who Died - Part A | 0 | 1 |
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.
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) - Part A | 1 | 1 |
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.
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A | 0 | 0 |
Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry. Grade 3=severe Grade 4=life-threatening Grade 5=death
| Participants | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Grade ≥ 3 Hematology | 1 | 0 |
| Grade ≥ 3 Serum Chemistry | 0 | 0 |
Maximum observed serum concentration of Analyte BMS-986016
| ug/mL | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Maximum Serum Concentration (Cmax) | 51.83 ± 16 | 40.00 ± NA |
Time of maximum observed serum concentration of Analyte BMS-986016
| hour | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Time to Maximum Concentration (Tmax) | 0.74 (0.58 to 1.00) | 0.50 (0.50 to 0.50) |
Area Under the Concentration-time Curve \[AUC(TAU)\] for Analyte BMS-986016
| h*ug/mL | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Area Under the Concentration-time Curve [AUC(TAU)] | 13160.63 ± 32 | 6745.58 ± NA |
Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558
| ug/mL | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Cycle 2 Day 1 - BMS986016 | 9.50 ± 68 | 2.39 ± NA |
| Cycle 4 Day 1 - BMS986016 | 20.52 ± 66 | — |
| Cycle 6 Day 1 - BMS986016 | 23.53 ± NA | — |
| Cycle 2 Day 1 - BMS-936558 | 40.32 ± 46 | 17.80 ± NA |
| Cycle 4 Day 1 - BMS-936558 | 79.80 ± 53 | — |
| Cycle 6 Day 1 - BMS-936558 | 91.87 ± NA | — |
Collected over All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 38 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 11 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A - Flat Dosing (AF) | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Part A - Age/Weight-based Dosing (AW) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Event | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| Facial painGeneral disorders and administration site conditions | 0/4 | 1/1 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 1/1 |
| Spinal cord compressionNervous system disorders | 0/4 | 1/1 |
| Skin infectionInfections and infestations | 1/4 | 0/1 |
| Event | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) |
|---|---|---|
| ToothacheGastrointestinal disorders | 0/4 | 1/1 |
| PyrexiaGeneral disorders and administration site conditions | 1/4 | 1/1 |
| Otitis mediaInfections and infestations | 0/4 | 1/1 |
| AnaemiaBlood and lymphatic system disorders | 2/4 | 0/1 |
| LymphopeniaBlood and lymphatic system disorders | 2/4 | 0/1 |
| DiarrhoeaGastrointestinal disorders | 2/4 | 0/1 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 2/4 | 0/1 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/4 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/4 | 0/1 |
| HyperthyroidismEndocrine disorders | 1/4 | 0/1 |
| Age, Categorical(Participants) | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) | Total |
|---|---|---|---|
| <=18 years | 4 | 1 | 5 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Part A - Flat Dosing (AF) | Part A - Age/Weight-based Dosing (AW) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 0 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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