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Trial record 1 of 1 for:    IMmotion150
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A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma (IMmotion150)

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ClinicalTrials.gov Identifier: NCT01984242
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : December 21, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Drug: Bevacizumab
Drug: Sunitinib
Enrollment 305
Recruitment Details  
Pre-assignment Details Total 305 participants were enrolled in this study. Participants enrolled in atezolizumab (except European Union [EU] participants) or sunitinib group could crossover to receive atezolizumab and bevacizumab combination therapy in case of disease progression.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression. Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Period Title: Overall Study
Started 101 103 101
Treated 101 103 100
Crossover Population 0 44 57
Completed 0 0 0
Not Completed 101 103 101
Reason Not Completed
Death             37             36             30
Withdrawal by Subject             2             2             5
Physician Decision             1             0             2
Lost to Follow-up             0             0             1
Other             1             0             1
Randomized, but not treated             0             0             1
Ongoing in Study             60             65             61
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib Total
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression. Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. Total of all reporting groups
Overall Number of Baseline Participants 101 103 101 305
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 103 participants 101 participants 305 participants
61.1  (10.8) 60.1  (10.2) 59.7  (10.8) 60.3  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 103 participants 101 participants 305 participants
Female
27
  26.7%
26
  25.2%
22
  21.8%
75
  24.6%
Male
74
  73.3%
77
  74.8%
79
  78.2%
230
  75.4%
1.Primary Outcome
Title Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population
Hide Description Progressive Disease (PD): at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm); appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Unit of Measure: percentage of participants
66.3 59.2 58.4
2.Primary Outcome
Title Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Median (95% Confidence Interval)
Unit of Measure: months
11.7
(8.4 to 17.3)
6.1
(5.4 to 13.6)
8.4
(7.0 to 14.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9819
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.69 to 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3580
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.82 to 1.71
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population included ITT participants with programmed death-ligand 1 (PD-L1) expression of greater than or equal to (>=) 1% on tumor-infiltrating immune cells.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Unit of Measure: percentage of participants
58.0 59.3 68.3
4.Primary Outcome
Title PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Median (95% Confidence Interval)
Unit of Measure: months
14.7
(8.2 to 25.1)
5.5
(3.0 to 13.9)
7.8
(3.8 to 10.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0952
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval 95%
0.38 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9172
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.63 to 1.67
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population included ITT participants whose tumor samples had sufficient material available for gene signature expression analyses. Participants with higher than median expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 45 44 42
Measure Type: Number
Unit of Measure: percentage of participants
55.6 61.4 73.8
6.Secondary Outcome
Title PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 45 44 42
Median (95% Confidence Interval)
Unit of Measure: months
17.5 [1] 
(10.3 to NA)
5.7
(3.2 to 16.7)
7.1
(4.2 to 8.7)
[1]
Data could not be estimated due to high number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0153
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.26 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5545
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.48 to 1.46
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 45 44 42
Measure Type: Number
Unit of Measure: percentage of participants
57.8 77.3 83.3
8.Secondary Outcome
Title PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 45 44 42
Median (95% Confidence Interval)
Unit of Measure: months
16.6 [1] 
(8.2 to NA)
5.5
(3.0 to 11.1)
6.8
(5.4 to 8.7)
[1]
Data could not be estimated due to high number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.28 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7675
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval 95%
0.56 to 1.53
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 61 55 60
Measure Type: Number
Unit of Measure: percentage of participants
59.0 58.2 65.0
10.Secondary Outcome
Title PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 61 55 60
Median (95% Confidence Interval)
Unit of Measure: months
13.8
(8.3 to 25.1)
5.7
(5.4 to 17.3)
8.2
(5.7 to 11.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1973
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval 95%
0.44 to 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7738
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.65 to 1.76
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 61 55 60
Measure Type: Number
Unit of Measure: percentage of participants
63.9 76.4 78.3
12.Secondary Outcome
Title PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 61 55 60
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(8.1 to 19.3)
5.5
(3.0 to 10.9)
7.1
(5.8 to 11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0830
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval 95%
0.43 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7141
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.70 to 1.69
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in ITT Population
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Unit of Measure: percentage of participants
71.3 75.7 75.2
14.Secondary Outcome
Title PFS Per RECIST v1.1 Via Investigator Assessment in ITT Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(8.2 to 13.5)
5.5
(3.0 to 8.4)
7.8
(5.7 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2541
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval 95%
0.59 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3103
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.86 to 1.63
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in IC1/2/3 Population
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Unit of Measure: percentage of participants
66.0 74.1 81.7
16.Secondary Outcome
Title PFS Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(8.1 to 16.7)
5.5
(3.0 to 10.9)
7.0
(5.6 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0351
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.37 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9769
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval 95%
0.64 to 1.54
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) Per RECIST v1.1 Via IRC Assessment in ITT Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.7
(22.78 to 41.69)
25.2
(17.20 to 34.76)
28.7
(20.15 to 38.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6492
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 2.97
Confidence Interval (2-Sided) 95%
-10.68 to 16.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5433
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -3.47
Confidence Interval 95%
-16.63 to 9.69
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Objective Response Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.0
(31.81 to 60.68)
27.8
(16.46 to 41.64)
26.7
(16.07 to 39.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 19.33
Confidence Interval (2-Sided) 95%
-0.28 to 38.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8719
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
-17.02 to 19.24
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in ITT Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.7
(25.46 to 44.77)
23.3
(15.54 to 32.66)
32.7
(23.67 to 42.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8068
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
-12.04 to 16.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1321
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -9.37
Confidence Interval 95%
-22.61 to 3.87
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.0
(33.66 to 62.58)
25.9
(14.96 to 39.65)
28.3
(17.45 to 41.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0199
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 19.67
Confidence Interval (2-Sided) 95%
-0.10 to 39.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7836
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -2.41
Confidence Interval (2-Sided) 95%
-20.50 to 15.68
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in ITT Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.6
(28.18 to 47.82)
25.2
(17.20 to 34.76)
33.7
(24.56 to 43.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6231
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.96
Confidence Interval (2-Sided) 95%
-10.23 to 18.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1816
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -8.42
Confidence Interval (2-Sided) 95%
-21.86 to 5.02
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.0
(37.42 to 66.34)
27.8
(16.46 to 41.64)
30.0
(18.85 to 43.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0111
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 22.00
Confidence Interval (2-Sided) 95%
2.11 to 41.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8209
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -2.22
Confidence Interval (2-Sided) 95%
-20.63 to 16.19
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in ITT Population
Hide Description PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Unit of Measure: percentage of participants
60.4 61.2 63.4
24.Secondary Outcome
Title PFS Per Modified RECIST Via Investigator Assessment in ITT Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Median (95% Confidence Interval)
Unit of Measure: months
16.7
(11.4 to 22.6)
10.9
(7.9 to 14.0)
9.9
(8.1 to 14.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0863
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval 95%
0.50 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5922
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.77 to 1.57
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in IC1/2/3 Population
Hide Description PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Unit of Measure: percentage of participants
52.0 59.3 75.0
26.Secondary Outcome
Title PFS Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Median (95% Confidence Interval)
Unit of Measure: months
21.7 [1] 
(11.1 to NA)
10.9
(5.4 to 14.0)
8.4
(5.8 to 11.3)
[1]
Data could not be estimated due to high number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval 95%
0.25 to 0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6566
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.56 to 1.44
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Duration of Response (DOR) Per RECIST v1.1 Via IRC Assessment in ITT Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 32 26 29
Median (95% Confidence Interval)
Unit of Measure: months
22.1 [1] 
(19.4 to NA)
NA [1] 
(23.4 to NA)
NA [1] 
(NA to NA)
[1]
Data could not be estimated due to high number of censored participants.
28.Secondary Outcome
Title DOR Per RECIST v1.1 Via Investigator Assessment in ITT Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 35 24 33
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.4 to NA)
NA [1] 
(NA to NA)
14.2 [1] 
(13.0 to NA)
[1]
Data could not be estimated due to high number of censored participants.
29.Secondary Outcome
Title DOR Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 23 15 16
Median (95% Confidence Interval)
Unit of Measure: months
22.1 [1] 
(19.4 to NA)
NA [1] 
(23.4 to NA)
NA [1] 
(12.0 to NA)
[1]
Data could not be estimated due to high number of censored participants.
30.Secondary Outcome
Title DOR Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 24 14 17
Median (95% Confidence Interval)
Unit of Measure: months
22.4 [1] 
(13.8 to NA)
NA [1] 
(NA to NA)
14.1 [1] 
(11.1 to NA)
[1]
Data could not be estimated due to high number of censored participants.
31.Secondary Outcome
Title DOR Per Modified RECIST Via Investigator Assessment in ITT Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 38 26 34
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.8 to NA)
NA [1] 
(NA to NA)
16.6 [1] 
(13.6 to NA)
[1]
Data could not be estimated due to high number of censored participants.
32.Secondary Outcome
Title DOR Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 26 15 18
Median (95% Confidence Interval)
Unit of Measure: months
22.4 [1] 
(19.4 to NA)
NA [1] 
(NA to NA)
16.6 [1] 
(11.3 to NA)
[1]
Data could not be estimated due to high number of censored participants.
33.Secondary Outcome
Title Percentage of Participants Who Died in ITT Population
Hide Description [Not Specified]
Time Frame Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Measure Type: Number
Unit of Measure: percentage of participants
38.6 35.0 30.7
34.Secondary Outcome
Title Overall Survival (OS) in ITT Population
Hide Description OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.
Time Frame Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 101 103 101
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(23.9 to NA)
NA [1] 
(30.2 to NA)
NA [1] 
(27.2 to NA)
[1]
Data could not be estimated due to high number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2867
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.80 to 2.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8039
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval 95%
0.65 to 1.73
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Percentage of Participants Who Died in IC1/2/3 Population
Hide Description [Not Specified]
Time Frame Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Measure Type: Number
Unit of Measure: percentage of participants
38.0 39.8 35.0
36.Secondary Outcome
Title OS in IC1/2/3 Population
Hide Description OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.
Time Frame Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
IC1/2/3 population
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 50 54 60
Median (95% Confidence Interval)
Unit of Measure: months
27.3 [1] 
(24.6 to NA)
30.2 [1] 
(23.3 to NA)
NA [1] 
(22.4 to NA)
[1]
Data could not be estimated due to high number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab and Bevacizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7879
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.47 to 1.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atezolizumab, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9065
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.52 to 1.80
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in Crossover Population
Hide Description Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Time Frame From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
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Hide Analysis Population Description
Crossover population included participants in atezolizumab or sunitinib arms who had crossed over to the atezolizumab and bevacizumab arm. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 41 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.4
(12.36 to 40.30)
27.8
(16.46 to 41.64)
38.Secondary Outcome
Title DOR Per RECIST v1.1 Via Investigator Assessment in Crossover Population
Hide Description DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.
Time Frame From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
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Hide Analysis Population Description
Crossover population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 10 15
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(7.2 to NA)
NA [1] 
(11.1 to NA)
[1]
Data could not be estimated due to high number of censored participants.
39.Secondary Outcome
Title Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Crossover Population
Hide Description PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Time Frame From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
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Hide Analysis Population Description
Crossover population
Arm/Group Title Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 44 57
Measure Type: Number
Unit of Measure: percentage of participants
59.1 68.4
40.Secondary Outcome
Title PFS Per RECIST v.1.1 Via Investigator Assessment in Crossover Population
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.
Time Frame From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover population
Arm/Group Title Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 44 57
Median (95% Confidence Interval)
Unit of Measure: months
12.6
(6.0 to 17.7)
8.3
(3.1 to 11.2)
41.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab
Hide Description This outcome measure was planned to be analyzed in ‘Atezolizumab’ and ‘Atezolizumab and Bevacizumab’ arms only.
Time Frame Cycle 1 Day 1 until treatment discontinuation (until data cut-off date 17 October 2016, up to approximately 2.75 years) (1 cycle=6 weeks)
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Hide Analysis Population Description
ATA evaluable population included participants at baseline who had a baseline ATA sample and post-baseline participants who had at least one ATA sample and had received at least one dose of study treatment.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 97 96
Measure Type: Number
Unit of Measure: percentage of participants
34.0 25.0
42.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Atezolizumab
Hide Description [Not Specified]
Time Frame 30 minutes after end of infusion on Cycle 1 Day 1 (1 cycle=6 weeks) (infusion length for first dose=60 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) evaluable population included participants who received at least one dose of study drug and had sufficient PK sample collected within the time specified in the protocol. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 95 93 41 53
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
335  (86.0) 358  (93.1) 418  (114) 314  (87.1)
43.Secondary Outcome
Title Minimum Serum Concentration (Cmin) of Atezolizumab
Hide Description [Not Specified]
Time Frame Pre-infusion (0 hour) on Day 1 of Cycles 2 and 4; Day 22 of Cycles 1, 2, and 4 (1 cycle=6 weeks) (infusion length=30-60 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 98 94 42 52
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Cycle 1 Day 22 Number Analyzed 98 participants 94 participants 42 participants 52 participants
72.6  (29.5) 79.9  (26.1) 174  (121) 73.2  (31.5)
Cycle 2 Day 1 Number Analyzed 89 participants 88 participants 38 participants 49 participants
122  (50.4) 125  (47.4) 158  (101) 106  (45.2)
Cycle 2 Day 22 Number Analyzed 85 participants 88 participants 38 participants 44 participants
152  (65.3) 159  (84.6) 164  (70.7) 141  (85.5)
Cycle 4 Day 1 Number Analyzed 79 participants 66 participants 28 participants 34 participants
183  (90.5) 192  (77.6) 154  (62.7) 174  (75.7)
Cycle 4 Day 22 Number Analyzed 71 participants 65 participants 25 participants 29 participants
190  (86.3) 200  (90.0) 163  (70.5) 172  (78.8)
44.Secondary Outcome
Title Cmax of Bevacizumab
Hide Description [Not Specified]
Time Frame 30 minutes after end of infusion on Day 1 of Cycles 1 and 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 86 34 44
Mean (Standard Deviation)
Unit of Measure: mcg/mL
89.8  (39.4) 433  (115) 455  (106)
45.Secondary Outcome
Title Cmin of Bevacizumab
Hide Description [Not Specified]
Time Frame For Atezolizumab and Bevacizumab Arm: at First-line treatment discontinuation (up to approximately 2.75 years); For Crossover Arms: pre-infusion (0 hour) on Day 1 of Cycle 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
Overall Number of Participants Analyzed 42 39 42
Mean (Standard Deviation)
Unit of Measure: mcg/mL
75.2  (72.1) 101  (48.7) 95.9  (43.9)
46.Secondary Outcome
Title M.D. Anderson Symptom Inventory (MDASI) Interference Score
Hide Description MDASI questionnaire comprises of 2 parts: symptoms (16 items), interference with daily life (6 items). Participants were asked to rate how much their symptoms interfered with general activity, mood, work, relations with other people, walking, and enjoyment of life during the last 24 hours. Each item in the interference score was answered on a scale of 0 (did not interfere) to 10 (interfered completely). The mean score of all 6 items was reported on the scale of 0 (did not interfere) to 10 (interfered completely).
Time Frame Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Reported Outcome (PRO)-evaluable population: randomized participants who had non-missing baseline assessment and at least 1 post-baseline assessment. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome. ‘Number Analyzed’=participants evaluable for this outcome at specified timepoint for each arm, respectively.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 96 95 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Day 1 Number Analyzed 96 participants 95 participants 93 participants
1.60  (1.97) 1.38  (2.03) 1.79  (2.39)
Cycle 1 Day 22 Number Analyzed 93 participants 88 participants 88 participants
2.08  (2.34) 1.26  (2.07) 3.16  (2.65)
Cycle 2 Day 1 Number Analyzed 86 participants 82 participants 80 participants
1.56  (1.82) 1.20  (1.72) 1.83  (2.19)
Cycle 2 Day 22 Number Analyzed 82 participants 80 participants 77 participants
1.57  (1.83) 1.04  (1.62) 2.50  (2.47)
Cycle 3 Day 1 Number Analyzed 77 participants 65 participants 69 participants
1.72  (2.15) 0.90  (1.43) 1.49  (2.01)
Cycle 3 Day 22 Number Analyzed 74 participants 63 participants 63 participants
1.66  (2.07) 1.01  (1.58) 2.20  (2.42)
Cycle 4 Day 1 Number Analyzed 72 participants 61 participants 62 participants
1.59  (2.11) 1.24  (1.99) 1.61  (2.24)
Cycle 4 Day 22 Number Analyzed 68 participants 61 participants 59 participants
1.68  (2.31) 1.26  (1.98) 1.92  (2.00)
Cycle 5 Day 1 Number Analyzed 60 participants 52 participants 53 participants
1.70  (2.29) 0.69  (1.11) 1.53  (1.96)
Cycle 5 Day 22 Number Analyzed 60 participants 50 participants 47 participants
1.80  (2.29) 0.67  (1.33) 1.97  (2.21)
Cycle 6 Day 1 Number Analyzed 57 participants 47 participants 49 participants
1.91  (2.54) 0.64  (1.13) 1.39  (1.76)
Cycle 6 Day 22 Number Analyzed 56 participants 49 participants 44 participants
1.80  (2.38) 0.63  (1.12) 2.00  (2.23)
Cycle 7 Day 1 Number Analyzed 51 participants 41 participants 41 participants
1.99  (2.49) 0.53  (0.78) 1.00  (1.09)
Cycle 7 Day 22 Number Analyzed 51 participants 40 participants 38 participants
2.01  (2.45) 0.59  (0.93) 1.15  (1.04)
Cycle 8 Day 1 Number Analyzed 50 participants 41 participants 39 participants
1.88  (2.26) 0.55  (0.85) 0.94  (1.04)
Cycle 8 Day 22 Number Analyzed 51 participants 38 participants 36 participants
1.81  (2.41) 0.58  (0.91) 1.34  (1.39)
Cycle 9 Day 1 Number Analyzed 46 participants 34 participants 33 participants
1.75  (2.24) 0.55  (0.90) 1.16  (1.22)
Cycle 9 Day 22 Number Analyzed 46 participants 32 participants 28 participants
1.64  (2.16) 0.58  (0.89) 1.57  (1.61)
Cycle 10 Day 1 Number Analyzed 45 participants 33 participants 28 participants
1.43  (1.82) 0.81  (1.13) 1.08  (1.40)
Cycle 10 Day 22 Number Analyzed 43 participants 33 participants 29 participants
1.55  (2.09) 0.70  (1.10) 1.49  (1.78)
Cycle 11 Day 1 Number Analyzed 41 participants 30 participants 29 participants
1.65  (2.13) 0.61  (0.95) 0.98  (1.00)
Cycle 11 Day 22 Number Analyzed 38 participants 28 participants 26 participants
1.35  (1.81) 0.78  (1.07) 1.47  (1.61)
Cycle 12 Day 1 Number Analyzed 39 participants 28 participants 29 participants
1.21  (1.69) 0.68  (1.15) 0.84  (0.83)
Cycle 12 Day 22 Number Analyzed 38 participants 25 participants 26 participants
1.51  (2.23) 0.53  (0.99) 1.41  (1.53)
Cycle 13 Day 1 Number Analyzed 35 participants 23 participants 24 participants
1.50  (2.16) 0.68  (1.07) 1.26  (1.45)
Cycle 13 Day 22 Number Analyzed 37 participants 23 participants 20 participants
1.45  (2.32) 0.67  (1.10) 1.32  (1.37)
Cycle 14 Day 1 Number Analyzed 35 participants 21 participants 23 participants
1.60  (2.24) 0.67  (0.95) 1.07  (1.31)
Cycle 14 Day 22 Number Analyzed 35 participants 19 participants 20 participants
1.40  (2.09) 0.63  (0.94) 1.50  (1.48)
Cycle 15 Day 1 Number Analyzed 31 participants 17 participants 21 participants
1.16  (1.74) 0.84  (1.16) 1.50  (1.64)
Cycle 15 Day 22 Number Analyzed 28 participants 13 participants 15 participants
1.48  (1.92) 0.71  (1.10) 2.08  (1.64)
Cycle 16 Day 1 Number Analyzed 25 participants 13 participants 14 participants
0.87  (0.99) 0.85  (1.40) 1.07  (1.22)
Cycle 16 Day 22 Number Analyzed 23 participants 9 participants 14 participants
0.72  (0.93) 0.87  (1.30) 2.04  (2.24)
Cycle 17 Day 1 Number Analyzed 18 participants 10 participants 8 participants
0.98  (0.99) 0.57  (0.75) 0.71  (0.95)
Cycle 17 Day 22 Number Analyzed 14 participants 8 participants 8 participants
0.73  (1.02) 0.65  (0.97) 1.21  (1.32)
Cycle 18 Day 1 Number Analyzed 12 participants 8 participants 7 participants
0.93  (1.07) 0.71  (0.98) 0.95  (1.15)
Cycle 18 Day 22 Number Analyzed 13 participants 6 participants 7 participants
0.79  (1.06) 0.33  (0.41) 1.05  (1.42)
Cycle 19 Day 1 Number Analyzed 11 participants 6 participants 7 participants
1.11  (1.25) 0.31  (0.34) 1.33  (1.66)
Cycle 19 Day 22 Number Analyzed 10 participants 5 participants 7 participants
0.97  (1.37) 0.30  (0.41) 1.55  (1.69)
Cycle 20 Day 1 Number Analyzed 8 participants 4 participants 5 participants
1.19  (1.31) 0.21  (0.42) 0.90  (1.07)
Cycle 20 Day 22 Number Analyzed 5 participants 4 participants 4 participants
1.10  (1.30) 0.04  (0.08) 1.67  (1.56)
Cycle 21 Day 1 Number Analyzed 5 participants 2 participants 3 participants
1.17  (1.42) 0.00  (0.00) 0.78  (1.07)
Cycle 21 Day 22 Number Analyzed 5 participants 1 participants 2 participants
1.23  (1.51) 0.00 [1]   (NA) 1.25  (1.53)
Cycle 22 Day 1 Number Analyzed 4 participants 1 participants 2 participants
0.54  (0.76) 0.00 [1]   (NA) 0.83  (0.71)
Cycle 22 Day 22 Number Analyzed 3 participants 1 participants 2 participants
0.94  (1.07) 0.00 [1]   (NA) 1.25  (1.53)
Cycle 23 Day 1 Number Analyzed 2 participants 1 participants 2 participants
1.67  (1.89) 0.00 [1]   (NA) 1.58  (2.00)
Cycle 23 Day 22 Number Analyzed 2 participants 1 participants 2 participants
1.25  (1.77) 0.00 [1]   (NA) 2.67  (2.36)
Cycle 24 Day 1 Number Analyzed 1 participants 1 participants 1 participants
2.33 [1]   (NA) 0.00 [1]   (NA) 1.67 [1]   (NA)
Cycle 24 Day 22 Number Analyzed 0 participants 1 participants 1 participants
0.00 [1]   (NA) 0.50 [1]   (NA)
Cycle 25 Day 1 Number Analyzed 0 participants 1 participants 0 participants
0.00 [1]   (NA)
Treatment discontinuation Number Analyzed 46 participants 39 participants 39 participants
2.54  (2.66) 2.29  (2.54) 3.49  (3.16)
[1]
Standard deviation was not estimable for single evaluable participant.
47.Secondary Outcome
Title Brief Fatigue Inventory (BFI) Fatigue Level Score
Hide Description BFI questionnaire comprises of 2 parts: fatigue level (3 items), interference with daily life (1 item with 6 sub-items). Each items in the fatigue level score was answered on a scale of 0 (no fatigue) to 10 (as bad as you can imagine). The mean score of all 3 items was reported on the scale of 0 (no fatigue) to 10 (as bad as you can imagine).
Time Frame Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)
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Hide Analysis Population Description
PRO-evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
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Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 95 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Day 1 Number Analyzed 93 participants 93 participants 92 participants
2.80  (2.64) 2.52  (2.72) 2.66  (2.74)
Cycle 1 Day 22 Number Analyzed 90 participants 86 participants 89 participants
3.80  (2.86) 2.55  (2.60) 4.42  (3.09)
Cycle 2 Day 1 Number Analyzed 86 participants 79 participants 79 participants
3.21  (2.61) 2.63  (2.69) 2.86  (2.76)
Cycle 2 Day 22 Number Analyzed 81 participants 82 participants 78 participants
3.15  (2.61) 2.57  (2.74) 3.69  (2.74)
Cycle 3 Day 1 Number Analyzed 76 participants 64 participants 69 participants
2.91  (2.60) 2.11  (2.42) 2.35  (2.44)
Cycle 3 Day 22 Number Analyzed 74 participants 62 participants 63 participants
2.93  (2.67) 2.31  (2.71) 3.60  (3.09)
Cycle 4 Day 1 Number Analyzed 72 participants 62 participants 62 participants
3.21  (2.66) 2.32  (2.86) 2.39  (2.47)
Cycle 4 Day 22 Number Analyzed 66 participants 61 participants 59 participants
3.06  (2.68) 2.33  (2.94) 3.15  (2.57)
Cycle 5 Day 1 Number Analyzed 59 participants 51 participants 53 participants
2.97  (2.83) 1.59  (2.03) 2.32  (2.62)
Cycle 5 Day 22 Number Analyzed 60 participants 50 participants 47 participants
3.02  (2.87) 1.34  (1.81) 2.91  (2.86)
Cycle 6 Day 1 Number Analyzed 57 participants 48 participants 49 participants
3.05  (2.83) 1.42  (1.90) 2.22  (2.48)
Cycle 6 Day 22 Number Analyzed 56 participants 49 participants 44 participants
3.23  (2.94) 1.39  (2.01) 3.09  (2.69)
Cycle 7 Day 1 Number Analyzed 51 participants 40 participants 40 participants
3.16  (2.81) 1.33  (1.91) 1.68  (1.75)
Cycle 7 Day 22 Number Analyzed 51 participants 41 participants 38 participants
2.86  (2.60) 1.24  (1.67) 2.16  (1.87)
Cycle 8 Day 1 Number Analyzed 50 participants 41 participants 39 participants
2.80  (2.56) 1.12  (1.68) 1.72  (1.70)
Cycle 8 Day 22 Number Analyzed 51 participants 38 participants 36 participants
2.88  (2.80) 1.24  (1.75) 2.58  (2.13)
Cycle 9 Day 1 Number Analyzed 46 participants 35 participants 34 participants
3.09  (2.81) 1.11  (1.55) 2.12  (2.48)
Cycle 9 Day 22 Number Analyzed 46 participants 32 participants 28 participants
2.80  (2.73) 1.19  (1.71) 2.64  (2.57)
Cycle 10 Day 1 Number Analyzed 45 participants 34 participants 28 participants
2.80  (2.58) 1.29  (1.88) 2.11  (2.23)
Cycle 10 Day 22 Number Analyzed 43 participants 33 participants 29 participants
2.91  (2.83) 1.33  (1.90) 2.24  (2.43)
Cycle 11 Day 1 Number Analyzed 40 participants 30 participants 28 participants
2.98  (2.71) 1.40  (1.96) 1.93  (1.65)
Cycle 11 Day 22 Number Analyzed 37 participants 29 participants 26 participants
2.59  (2.44) 1.72  (2.23) 2.42  (2.12)
Cycle 12 Day 1 Number Analyzed 39 participants 28 participants 29 participants
2.31  (2.25) 1.25  (1.96) 1.66  (1.67)
Cycle 12 Day 22 Number Analyzed 38 participants 25 participants 26 participants
2.79  (2.46) 1.44  (2.12) 2.27  (2.05)
Cycle 13 Day 1 Number Analyzed 36 participants 23 participants 24 participants
2.69  (2.57) 1.65  (2.17) 2.08  (1.56)
Cycle 13 Day 22 Number Analyzed 37 participants 22 participants 20 participants
2.97  (2.97) 1.55  (2.13) 2.60  (2.28)
Cycle 14 Day 1 Number Analyzed 35 participants 20 participants 23 participants
2.94  (2.94) 1.45  (2.14) 2.30  (2.34)
Cycle 14 Day 22 Number Analyzed 35 participants 18 participants 20 participants
2.83  (2.85) 1.61  (2.00) 2.60  (2.09)
Cycle 15 Day 1 Number Analyzed 30 participants 17 participants 20 participants
2.73  (2.56) 1.76  (2.19) 2.60  (2.33)
Cycle 15 Day 22 Number Analyzed 28 participants 13 participants 16 participants
2.61  (2.79) 0.92  (1.12) 2.94  (1.61)
Cycle 16 Day 1 Number Analyzed 25 participants 13 participants 14 participants
1.88  (1.99) 1.54  (2.07) 2.21  (2.42)
Cycle 16 Day 22 Number Analyzed 23 participants 9 participants 13 participants
1.70  (1.61) 2.11  (2.15) 2.85  (2.19)
Cycle 17 Day 1 Number Analyzed 18 participants 10 participants 8 participants
1.78  (1.59) 1.60  (1.96) 1.50  (1.51)
Cycle 17 Day 22 Number Analyzed 14 participants 8 participants 8 participants
2.00  (1.80) 2.13  (2.42) 2.38  (1.60)
Cycle 18 Day 1 Number Analyzed 13 participants 8 participants 7 participants
2.23  (1.74) 1.88  (2.23) 1.71  (1.70)
Cycle 18 Day 22 Number Analyzed 13 participants 6 participants 7 participants
1.92  (2.14) 1.67  (2.07) 2.14  (2.19)
Cycle 19 Day 1 Number Analyzed 12 participants 6 participants 7 participants
2.17  (2.48) 1.50  (1.97) 2.29  (3.30)
Cycle 19 Day 22 Number Analyzed 10 participants 5 participants 7 participants
1.90  (2.42) 1.40  (2.19) 3.29  (2.43)
Cycle 20 Day 1 Number Analyzed 8 participants 4 participants 5 participants
3.00  (3.16) 1.25  (2.50) 1.80  (1.30)
Cycle 20 Day 22 Number Analyzed 5 participants 4 participants 4 participants
2.40  (3.05) 1.50  (3.00) 2.25  (2.06)
Cycle 21 Day 1 Number Analyzed 5 participants 2 participants 3 participants
2.60  (2.97) 2.50  (3.54) 1.67  (1.53)
Cycle 21 Day 22 Number Analyzed 5 participants 1 participants 2 participants
2.40  (1.95) 0.00 [1]   (NA) 2.00  (1.41)
Cycle 22 Day 1 Number Analyzed 4 participants 1 participants 2 participants
1.25  (1.89) 0.00 [1]   (NA) 2.00  (1.41)
Cycle 22 Day 22 Number Analyzed 3 participants 1 participants 2 participants
1.33  (2.31) 0.00 [1]   (NA) 3.00  (2.83)
Cycle 23 Day 1 Number Analyzed 2 participants 1 participants 2 participants
2.50  (3.54) 0.00 [1]   (NA) 2.00  (2.83)
Cycle 23 Day 22 Number Analyzed 2 participants 1 participants 2 participants
2.00  (2.83) 0.00 [1]   (NA) 4.50  (3.54)
Cycle 24 Day 1 Number Analyzed 1 participants 1 participants 1 participants
4.00 [1]   (NA) 0.00 [1]   (NA) 2.00 [1]   (NA)
Cycle 24 Day 22 Number Analyzed 0 participants 1 participants 1 participants
0.00 [1]   (NA) 0.00 [1]   (NA)
Cycle 25 Day 1 Number Analyzed 0 participants 1 participants 0 participants
0.00 [1]   (NA)
Treatment discontinuation Number Analyzed 46 participants 39 participants 40 participants
3.74  (2.82) 3.95  (3.27) 3.75  (3.09)
[1]
Standard deviation was not estimable for single evaluable participant.
48.Other Pre-specified Outcome
Title EuroQoL 5 Dimension (EQ-5D) Questionnaire Score
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)
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As this outcome was pre-specified as an exploratory outcome, no results are reported.
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib
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Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to approximately 2.75 years
Adverse Event Reporting Description Safety-evaluable population included all participants who received at least one dose of any study medication. Adverse events were reported separately for crossed over participants.
 
Arm/Group Title Atezolizumab and Bevacizumab Atezolizumab Sunitinib Atezolizumab (Crossover) Sunitinib (Crossover)
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression. Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. Among the participants assigned to atezolizumab initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle. Among the participants assigned to sunitinib initially, those participants who upon disease progression, crossed over to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination, were included in this group. Atezolizumab 1200 mg and bevacizumab 15 mg/kg were administered as IV infusions q3w on Day 1 and Day 22 of each 6-week cycle.
All-Cause Mortality
Atezolizumab and Bevacizumab Atezolizumab Sunitinib Atezolizumab (Crossover) Sunitinib (Crossover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
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Atezolizumab and Bevacizumab Atezolizumab Sunitinib Atezolizumab (Crossover) Sunitinib (Crossover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/101 (43.56%)   35/103 (33.98%)   24/100 (24.00%)   13/44 (29.55%)   18/57 (31.58%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/101 (0.00%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Febrile neutropenia * 1  0/101 (0.00%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Histiocytosis haematophagic * 1  0/101 (0.00%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Cardiac disorders           
Angina pectoris * 1  2/101 (1.98%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Atrial fibrillation * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  0/57 (0.00%) 
Cardiac failure congestive * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Cardiomyopathy * 1  0/101 (0.00%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  0/57 (0.00%) 
Myocardial infarction * 1  1/101 (0.99%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Tachycardia * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Ear and labyrinth disorders           
Vertigo * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Endocrine disorders           
Adrenal insufficiency * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  0/57 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  1/57 (1.75%) 
Ascites * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Autoimmune pancreatitis * 1  0/101 (0.00%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Constipation * 1  0/101 (0.00%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  2/57 (3.51%) 
Diarrhoea * 1  2/101 (1.98%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Gastritis * 1  0/101 (0.00%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  1/57 (1.75%) 
Gastrointestinal haemorrhage * 1  0/101 (0.00%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Gastrointestinal inflammation * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Gastrooesophageal reflux disease * 1  0/101 (0.00%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Intestinal haemorrhage * 1  0/101 (0.00%)  1/103 (0.97%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Intestinal obstruction * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Mesenteric vein thrombosis * 1  0/101 (0.00%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Nausea * 1  0/101 (0.00%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  3/57 (5.26%) 
Pancreatic fistula * 1  0/101 (0.00%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  1/57 (1.75%) 
Pancreatitis * 1  1/101 (0.99%)  1/103 (0.97%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%) 
Pancreatitis acute * 1  0/101 (0.00%)  0/103 (0.00%)  0/100 (0.00%)  1/44 (2.27%)  0/57 (0.00%) 
Peritoneal haemorrhage * 1  0/101 (0.00%)  0/103 (0.00%)  1/100 (1.00%)  0/44 (0.00%)  0/57 (0.00%) 
Rectal haemorrhage * 1  1/101 (0.99%)  0/103 (0.00%)  0/100 (0.00%)  0/44 (0.00%)  0/57 (0.00%)