<
td>Measure:td><
td>ORR according to immune-related Response Evaluation Criteria In Solid Tumors (iRECIST) assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>For the secondary efficacy analysis, ORR is defined
as the percentage of participants whose best response based on imaging is CR (disappearance of all lesions) or PR (≥30% decrease in the
SOD of target lesions, taking
as reference the baseline sum diameters) according to iRECIST
as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
At initial Progressive
Disease (PD) by RECIST 1.1, if participant is clinically stable the investigator may continue to treat and scan again 4-8 weeks later to see if PD confirmed by iRECIST criteria.td>
<
td>Measure:td><
td>
Duration of Response (DOR) according to RECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>For participants who demonstrate CR or PR according to RECIST 1.1
as assessed by BICR, DOR is defined
as the time from the earliest
date of qualifying response (CR or PR) until earliest
date of
disease progression or death from any cause, whichever comes first. DOR will be censored
at the last tumor assessment
date if a responder does not have PD or death.td>
<
td>Measure:td><
td>DOR according to iRECIST assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>For participants who demonstrate CR or PR according to iRECIST
as assessed by BICR, DOR is defined
as the time from the earliest
date of qualifying response (CR or PR) until earliest
date of
disease progression or death from any cause, whichever comes first. DOR will be censored
at the last tumor assessment
date if a responder does not have PD or death. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.td>
<
td>Measure:td><
td>
Disease Control Rate (DCR) according to RECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>DCR is defined
as the percentage of participants in the analysis population who have CR (disappearance of all lesions), PR (≥30% decrease in the
SOD of target lesions, taking
as reference the baseline sum diameters), or stable
disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD). Responses are according to RECIST 1.1
as assessed by BICR.td>
<
td>Measure:td><
td>DCR according to iRECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>DCR is defined
as the percentage of participants in the analysis population who have CR (disappearance of all lesions), PR (≥30% decrease in the
SOD of target lesions, taking
as reference the baseline sum diameters), or stable
disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD). Responses are according to iRECIST 1.1
as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.td>
<
td>Measure:td><
td>Time to Response (TTR) according to RECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>TTR is defined
as the time from the
date of enrollment day to the first
date of confirmed CR (disappearance of all lesions) or PR (≥30% decrease in the
SOD of target lesions, taking
as reference the baseline sum diameters). Responses are according to RECIST 1.1
as assessed by BICR.td>
<
td>Measure:td><
td>TTR according to iRECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>TTR is defined
as the time from the
date of enrollment day to the first
date of confirmed CR (disappearance of all lesions) or PR (≥30% decrease in the
SOD of target lesions, taking
as reference the baseline sum diameters). Responses are according to iRECIST 1.1
as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.td>
<
td>Measure:td><
td>Progression-free Survival (PFS) according to RECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>PFS is defined
as the time from the
date of enrollment day to the first documented
disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1
as assessed by BICR.td>
<
td>Measure:td><
td>PFS according to iRECIST 1.1 assessed by BICRtd><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>PFS is defined
as the time from the
date of enrollment day to the first documented
disease progression or death due to any cause, whichever occurs first. Responses are according to iRECIST 1.1
as assessed by BICR. iRECIST is a modification to RECIST that takes into account unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.td>
<
td>Measure:td><
td>Overall survival (OS)td><
td>Time Frame:td><
td>Up to ~2 yearstd><
td>Safety Issue:td><
td/><
td>Description:td><
td>OS is defined
as the time from the
date of enrollment day to death due to any cause. Participants without documented death
at the time of the final analysis will be censored
at the
date of the last follow-up.td>
<
td>Measure:td><
td>Adverse events (AEs)td><
td>Time Frame:td><
td>From time of allocation up to 30 days following cessation of study treatment (up to ~2 years)td><
td>Safety Issue:td><
td/><
td>Description:td><
td>The number of participants that experience an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or
disease (new or exacerbated) temporally associated with the use of a study treatmenttd>
<
td>Measure:td><
td>Treatment discontinuations due to AEstd><
td>Time Frame:td><
td>From time of allocation up to 30 days following cessation of study treatment (up to ~2 years)td><
td>Safety Issue:td><
td/><
td>Description:td><
td>The number of participants that discontinue study
drug due to an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or
disease (new or exacerbated) temporally associated with the use of a study treatment.td>