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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Specified Dose on Specified Days
Specified Dose on Specified Days
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.
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Local Institution - 0077
Birmingham, Alabama, United States
Local Institution - 0024
Phoenix, Arizona, United States
Local Institution - 0035
Palo Alto, California, United States
Local Institution - 0032
New Haven, Connecticut, United States
Local Institution - 0066
Fort Myers, Florida, United States
Local Institution - 0073
Baltimore, Maryland, United States
Local Institution - 0025
Minneapolis, Minnesota, United States
Local Institution - 0020
Jackson, Mississippi, United States
Local Institution - 0071
Hackensack, New Jersey, United States
Local Institution - 0060
New York, New York, United States
...and 41 more locations
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