CBR is defined as the number of participants who have at least 1 confirmed response of complete response (CR) or partial response (PR) (only if participant has measurable disease), or stable disease (SD) >= 24 weeks (or non-CR/non-progressive disease (PD) >=24 weeks for participants with non-measurable disease) prior to any evidence of progression.

Full Analysis Set consisted of all participants who received >=1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

Best overall response was summarized categorically based on the four RECIST categories: CR, PR, SD and PD.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 4 are reported.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 6 are reported.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 8 are reported.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 10 are reported.

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 12 are reported.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.

ORR is defined as the number of participants with measurable disease who have at least 1 confirmed response of CR or PR prior to any evidence of progression (as defined by RECIST v1.1).

Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.