A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 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. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)

Population: All treated participants in Part 2

Number of participants with Adverse events

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

Population: All treated participants in Part 1

Number of participants with Adverse Events leading to death.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

Population: All treated participants in Part 1

Number of participants with Adverse events

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

Population: All treated participants in Part 1

Number of participants with clinical laboratory abnormalities.

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

Population: All treated participants in Part 1

Number of participants with Adverse events

Time frame: From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

Population: All treated participants in Part 1

AI - Accumulation index; ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC (TAU) in Part 1. Here SS = Steady State Here FD = First Dose

Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

AUC(0-T) - Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration. in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1

AUC(TAU) - Area under the concentration-time curve in one dosing interval in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A ipilimumab treatment, so no data was collected

The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per BICR.

Time frame: Approximately 5.92 Months

Population: All treated participants in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

Population: All confirmed responders per BICR in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

Population: All Treated participtants in Part 2

Ceoinf - Serum concentration achieved at the end of study drug infusion in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1

CLT - Total body clearance in Part 1.

Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1 with CLT data collected, Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

Cmax - Maximum observed serum concentration in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1

Css-avg - Average concentration over a dosing interval (AUC(TAU)/tau) in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A ipilimumab treatment, so no data was collected

Ctau - Concentration at the end of dosing interval in Part 1. The Ctau is equivilant to the CTrough at these time points.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1

The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per investigator.

Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)

Population: All treated participants in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

Population: All confirmed responders per investigator in Part 2

ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 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. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

Time frame: between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by the Investigator. (Approximately on average 2 Months)

Population: All treated participants in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

Time frame: From first dose to 100 days post last dose (approximately 102 weeks)

Population: All Treated participtants in Part 2

Number of participants with Ipilimumab Anti Drug Antibodies in Part 1.

Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

Population: All Treated Subjects with Baseline and at Least One Post-baseline Evaluable ADA Assessment (Part 1)

Number of participants with nivolumab Anti Drug Antibodies in Part 1.

Time frame: At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

Population: All Treated Subjects with Baseline and at Least One Post-baseline Evaluable ADA Assessment (Part 1)

T-HALFeff - Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax, or Ctau) in Part 1.

Time frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

Tmax - Time of maximum observed serum concentration in Part 1.

Time frame: At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

Population: PK Evaluable Population in Part 1