| Primary | 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 | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00066.3
- OG00159.2
- OG00258.4
|
|
| |
| Primary | Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Primary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Primary | PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | 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. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature | 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. | Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature | 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. | Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | 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 | 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. | Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in ITT Population | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 |
|
| Secondary | PFS Per RECIST v1.1 Via Investigator Assessment in ITT Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in IC1/2/3 Population | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 |
|
| Secondary | PFS Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) Per RECIST v1.1 Via IRC Assessment in ITT Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in ITT Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in ITT Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population | 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in ITT Population | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | |
|
| Secondary | PFS Per Modified RECIST Via Investigator Assessment in ITT Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 |
|
| Secondary | Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in IC1/2/3 Population | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib |
|
| Secondary | PFS Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 |
|
| Secondary | Duration of Response (DOR) Per RECIST v1.1 Via IRC Assessment in ITT Population | 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. | ITT population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 |
|
| Secondary | DOR Per RECIST v1.1 Via Investigator Assessment in ITT Population | 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. | ITT population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 |
|
| Secondary | DOR Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population | 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. | IC1/2/3 population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 |
|
| Secondary | DOR Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population | 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. | IC1/2/3 population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 |
|
| Secondary | DOR Per Modified RECIST Via Investigator Assessment in ITT Population | 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. | ITT population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | DOR Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population | 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. | IC1/2/3 population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
|
| Secondary | Percentage of Participants Who Died in ITT Population | | | Posted | | Number | | percentage of participants | | Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | 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. |
|
| Secondary | Overall Survival (OS) in ITT Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | 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. |
|
| Secondary | Percentage of Participants Who Died in IC1/2/3 Population | | | Posted | | Number | | percentage of participants | | Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | 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. |
|
| Secondary | OS in IC1/2/3 Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Sunitinib | 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. |
|
| Secondary | Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in Crossover Population | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab (Crossover) | 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. | | OG001 |
|
| Secondary | DOR Per RECIST v1.1 Via Investigator Assessment in Crossover Population | 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. | Crossover population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab (Crossover) | 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. |
|
| Secondary | Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Crossover Population | 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. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab (Crossover) | 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. | | OG001 | Sunitinib (Crossover) | 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. |
|
| Secondary | PFS Per RECIST v.1.1 Via Investigator Assessment in Crossover Population | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab (Crossover) | 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. | | OG001 | Sunitinib (Crossover) | 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. |
|
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab | This outcome measure was planned to be analyzed in 'Atezolizumab' and 'Atezolizumab and Bevacizumab' arms only. | 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. | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
| |
| Secondary | Maximum Serum Concentration (Cmax) of Atezolizumab | | 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. | Posted | | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | | 30 minutes after end of infusion on Cycle 1 Day 1 (1 cycle=6 weeks) (infusion length for first dose=60 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Atezolizumab (Crossover) | 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. |
|
| Secondary | Minimum Serum Concentration (Cmin) of Atezolizumab | | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. | | OG002 | Atezolizumab (Crossover) | 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. |
|
| Secondary | Cmax of Bevacizumab | | PK evaluable population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/mL | | 30 minutes after end of infusion on Day 1 of Cycles 1 and 2 (1 cycle=6 weeks) (infusion length=30-90 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab (Crossover) | 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. | | OG002 | Sunitinib (Crossover) | 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. |
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| Secondary | Cmin of Bevacizumab | | PK evaluable population. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mcg/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab (Crossover) | 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. | | OG002 | Sunitinib (Crossover) | 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. |
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| Secondary | M.D. Anderson Symptom Inventory (MDASI) Interference Score | 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | 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) | | | | ID | Title | Description |
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| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
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| Secondary | Brief Fatigue Inventory (BFI) Fatigue Level Score | 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | 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) | | | | ID | Title | Description |
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| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
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| Other Pre-specified | EuroQoL 5 Dimension (EQ-5D) Questionnaire Score | 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. | As this outcome was pre-specified as an exploratory outcome, no results are reported. | Posted | | | | | | 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) | | | | ID | Title | Description |
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| OG000 | Atezolizumab and Bevacizumab | 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. | | OG001 | Atezolizumab | 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. |
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