A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Disease Control Rate Assessed by BICR

Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Duration of Response Assessed by BICR

Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Progression Free Survival(PFS) Assessed by BICR

PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Objective Response Rate Assessed by Investigator

Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Disease Control Rate Assessed by Investigator

Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Duration of Response Assessed by Investigator

Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Progression Free Survival(PFS) Assessed by Investigator

PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Overall Survival (OS)

Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Number of Participants With Adverse Events

Number of participants with an Adverse Event. An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

Number of Participants With Serious Adverse Events

Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

Number of Participants With Adverse Events Leading to Discontinuation

Number of participants with Adverse Events Leading to Discontinuation

Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

Death Summary

Number of participants who died.

Time frame: From randomization to primary completion date (Approximately 29.5 Months)

Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

Number of participants with clinical laboratory abnormalities in specific liver tests

Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests

Number of participants with clinical laboratory abnormalities in thyroid tests

Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.