The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Specified dose on specified days
Local Institution - 0001
Beijing, Beijing Municipality, China
Local Institution - 0002
Fuzhou, Fujian, China
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 3 years
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time frame: Approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Approximately 3 years
Number of Deaths
Time frame: Approximately 3 years
Number of Participants with AEs Leading to Discontinuation
Time frame: Approximately 3 years
Number of Participants with Laboratory Abnormalities
Time frame: Approximately 3 years
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time frame: Approximately 3 years
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time frame: Approximately 3 years
Trough Observed Plasma Concentration (Ctrough) of Relatlimab
Time frame: Approximately 3 years
Concentration of Relatlimab at the end of a dosing interval (Ctau)
Time frame: Approximately 3 years
Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
Time frame: Approximately 3 years
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
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Time frame: Approximately 3 years
Total Body Clearance (CLT) of Relatlimab
Time frame: Approximately 3 years
Observed Concentration of Relatlimab at End of Infusion (Ceoi)
Time frame: Approximately 3 years
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Approximately 3 years
Disease Control Rate (DCR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Duration of Response (DOR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Best Overall Response (BOR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Ctrough of Nivolumab
Time frame: Approximately 3 years
Ceoi of Nivolumab
Time frame: Approximately 3 years
Number of Anti-drug Antibodies (ADAs) to Relatlimab
Time frame: Approximately 3 years
Number of ADAs to Nivolumab
Time frame: Approximately 3 years