The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Specified dose on specified days
Specified dose on specified days
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Number of Participants with Adverse Events (AEs)
Time frame: Up to 123 Weeks
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time frame: Up to 123 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 123 Weeks
Number of Deaths
Time frame: Up to 123 Weeks
Number of Participants with AEs Leading to Discontinuation
Time frame: Up to 123 Weeks
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 123 Weeks
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 123 Weeks
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time frame: Up to 123 Weeks
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time frame: Up to 123 Weeks
Trough-observed serum concentration (Ctrough) of Relatlimab
Time frame: Up to 123 Weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Up to 123 Weeks
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Disease Control Rate (DCR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Duration of Response (DOR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Best Overall Response (BOR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Ctrough of Nivolumab
Time frame: Up to 123 Weeks
Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab
Time frame: Up to 123 Weeks
Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab
Time frame: Up to 123 Weeks
Percentage of Participants Positive for ADAs to Nivolumab
Time frame: Up to 123 Weeks