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
Incidence of dose-limiting toxicities (DLTs)
DLT evaluation window is 4 weeks from start of treatment. Safety evaluation will continue up to 135 days following last dose.
Time frame: Up to 135 days following last dose
Maximum tolerated dose or Recommended phase 2 dose (MTD/RP2D)
Time frame: Up to 135 days following last dose
Number of participants with Adverse Events (AEs)
Time frame: Up to 135 days following last dose
Number of participants with serious adverse events (SAEs)
Time frame: Up to 135 days following last dose
Number of participants with AEs leading to discontinuation
Time frame: Up to 135 days following last dose
Number of deaths
Time frame: Up to 2 years from the last treatment of last participant
Number of participants with clinical laboratory abnormalities
Time frame: Up to 135 days following last dose
Maximum observed plasma concentration (Cmax)
Time frame: Up to 96 weeks
Trough observed concentration (Ctrough)
Time frame: Up to 96 weeks
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 96 weeks
Area Under the Curve within a dosing interval (AUC(TAU))
Time frame: Up to 96 weeks
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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
Complete Metabolic Response (CMR) Rate defined as the proportion of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria
Time frame: Up to 2 years from the last treatment of last participant
Number of participants with AEs
Time frame: Up to 135 days following last dose
Number of participants with SAEs
Time frame: Up to 135 days following last dose
Number of participants with AEs leading to discontinuation
Time frame: Up to 135 days following last dose
Number of deaths
Time frame: Up to 2 years from the last treatment of last participant
Number of participants with clinical laboratory abnormalities
Time frame: Up to 135 days following last dose
Overall Response Rate (ORR) defined as the proportion of all response- evaluable participants who achieve a best response of CMR or partial metabolic response (PMR) using the Lugano 2014 classification
Time frame: Up to 2 years from the last treatment of last participant