PFS was defined as the time from the first day of study drug administration to the earlier of progressive disease (PD) per RECIST V1.1 or death due to any cause. Per RECIST V1.1, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline. In addition to the relative increase of 20%, the SoD also demonstrated an absolute increase of at least 5 mm.

OS is defined as the time from the first day of study drug administration to death due to any cause.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment. Severity grade was defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. As per the NCI-CTCAE, Grade 1 scales as mild; Grade 2 scales as moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.

A serious TEAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically important due to other reasons than the above-mentioned criteria. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

Clinical laboratory tests included tests of serum chemistry, hematology, urine chemistry, coagulation, and thyroid function prespecified in the protocol. Only those categories are reported which are considered clinically significant abnormal laboratory values post baseline, as assessed by the investigator.

Vital signs included diastolic blood pressure (DBP) and systolic blood pressure (SBP) in the sitting position, pulse rate respiratory rate temperature, and weight. Abnormal vital sign values considered by the investigator to be clinically significant are reported as categories.

Race and Ethnicity were not collected from any participant.

MSKCC was used to determine the prognostic risk score in participants with advanced RCC. The risk factors for RCC were graded as 0 to 3, where 0=favorable, 1=intermediate, 2 or 3= poor.

Heng criteria assess prognostic risk in RCC participants. The score ranges from 0 to 6, where 0 (favorable), 1-2 (intermediate), and 3-6 (poor).

Karnofsky PS is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky PS score is 11 level score which ranges between 0 (dead) to 100 (normal, no complaints, no evidence of disease). Higher score means higher ability to perform daily tasks. Only categories with participants are reported.

The ECOG scale assess participant's ability to perform daily activities as:Grade 0:fully active,able to carry on pre-disease activities without restriction;Grade 1:restricted in physically strenuous activity,but ambulatory,able to carry work of light or sedentary nature;Grade 2:ambulatory,capable of all self-care but unable to carry out any work activities;Grade 3:capable of only limited self-care,confined to bed or chair >50% of waking hours;Grade 4:completely disabled.Cannot carry on any self-care,totally confined to bed or chair;Grade 5:death.Only categories with participants are reported.

CBR was defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST V1.1. Response and progression were evaluated by IRC per RECIST V1.1. CR and PR required confirmation by a subsequent evaluation conducted ≥28 days later and an assessment of SD was made at least 8 weeks after the first day of study drug. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

FAS included all participants who received at least one dose of study drug.

PFS was defined as the time from the first day of study drug administration to the earlier of progressive disease (PD) per RECIST V1.1 or death due to any cause. Per RECIST V1.1, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline. In addition to the relative increase of 20%, the SoD also demonstrated an absolute increase of at least 5 mm.

FAS included all participants who received at least one dose of study drug.

OS is defined as the time from the first day of study drug administration to death due to any cause.

FAS included all participants who received at least one dose of study drug.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

Safety Analysis Set included all participants who received at least one dose of study drug.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment. Severity grade was defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. As per the NCI-CTCAE, Grade 1 scales as mild; Grade 2 scales as moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.

Safety Analysis Set included all participants who received at least one dose of study drug.

A serious TEAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically important due to other reasons than the above-mentioned criteria. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

Safety Analysis Set included all participants who received at least one dose of study drug.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

Safety Analysis Set included all participants who received at least one dose of study drug.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.

Safety Analysis Set included all participants who received at least one dose of study drug.

Clinical laboratory tests included tests of serum chemistry, hematology, urine chemistry, coagulation, and thyroid function prespecified in the protocol. Only those categories are reported which are considered clinically significant abnormal laboratory values post baseline, as assessed by the investigator.

Safety Analysis Set included all participants who received at least one dose of study drug.

Vital signs included diastolic blood pressure (DBP) and systolic blood pressure (SBP) in the sitting position, pulse rate respiratory rate temperature, and weight. Abnormal vital sign values considered by the investigator to be clinically significant are reported as categories.

Safety Analysis Set included all participants who received at least one dose of study drug. Number analyzed are the number of participants with data available for analyses in the given category.