Trial · NCT02420821
A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
NCT02420821, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC). Trials, record NCT02420821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02420821
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
- NCT number
- NCT02420821
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 915 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Renal Cell Carcinoma
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Sunitinib
- First posted
- 2015-04-20
- Last updated
- 2023-01-30
- Other registries' IDs
- eudract:2014-004684-20
- Results first posted
- 2018-10-03
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (\>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 millimeters (mm); \>/=1 new lesion(s); and/or unequivocal progression of existing non-TLs. |
| Primary | Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed \>/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. |
| Primary | Percentage of Participants Who Died of Any Cause in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Percentage of participants who died of any cause was reported. |
| Primary | Overall Survival (OS) in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Percentage of participants who died of any cause was reported. |
| Secondary | OS in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. |
| Secondary | PFS as Determined by an IRC According to RECIST v1.1 in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. |
| Secondary | PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization. | percentage of participants | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died of Any Cause in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the PD-L1-Selected Population. | percentage of participants | NUMBER |
| SECONDARY | OS in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by an IRC According to RECIST v1.1 in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group445
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Sunitinib | 69.6 | percentage of participants | ||
Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Atezolizumab + Bevacizumab | 58.4 | percentage of participants | ||
| Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | Sunitinib | 7.5 | 95% Confidence Interval 6.8 to 9.7 | months | |
| Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | Atezolizumab + Bevacizumab | 11.2 | 95% Confidence Interval 8.6 to 14.3 | months | |
| Percentage of Participants Who Died of Any Cause in ITT Population | Sunitinib | 55.3 | percentage of participants | ||
| Percentage of Participants Who Died of Any Cause in ITT Population | Atezolizumab + Bevacizumab | 54.8 | percentage of participants | ||
| Overall Survival (OS) in ITT Population | Sunitinib | 35.3 | 95% Confidence Interval 28.6 to 42.1 | months | |
| Overall Survival (OS) in ITT Population | Atezolizumab + Bevacizumab | 36.1 | 95% Confidence Interval 31.5 to 42.3 | months | |
| Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Sunitinib | 56.5 | percentage of participants | ||
| Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Atezolizumab + Bevacizumab | 53.9 | percentage of participants |
1 to 10 of 445Source ClinicalTrials.gov
See all 445 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib | 461 | |
| Overall Study | STARTED | Atezolizumab + Bevacizumab | 454 | |
| Overall Study | COMPLETED | Sunitinib | 1 | |
| Overall Study | COMPLETED | Atezolizumab + Bevacizumab | 1 | |
| Overall Study | NOT COMPLETED | Sunitinib | 460 | |
| Overall Study | NOT COMPLETED | Atezolizumab + Bevacizumab | 453 |
Source ClinicalTrials.gov
Adverse events706
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Sunitinib | 104 | 446 | 177 |
| other | ANAEMIA | Blood and lymphatic system disorders | Atezolizumab + Bevacizumab | 51 | 451 | 81 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Sunitinib | 31 | 446 | 65 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Atezolizumab + Bevacizumab | 5 | 451 | 13 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Sunitinib | 62 | 446 | 157 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Atezolizumab + Bevacizumab | 5 | 451 | 7 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Sunitinib | 80 | 446 | 172 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Atezolizumab + Bevacizumab | 15 | 451 | 36 |
| other | HYPERTHYROIDISM | Endocrine disorders | Sunitinib | 14 | 446 | 16 |
| other | HYPERTHYROIDISM | Endocrine disorders | Atezolizumab + Bevacizumab | 31 | 451 | 32 |
1 to 10 of 706Source ClinicalTrials.gov
See all 706 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | 270 | 461 |
| Total, all-cause mortality | Atezolizumab + Bevacizumab | 263 | 454 |
| Total, other adverse events | Sunitinib | 435 | 446 |
| Total, other adverse events | Atezolizumab + Bevacizumab | 437 | 451 |
| Total, serious adverse events | Sunitinib | 169 | 446 |
| Total, serious adverse events | Atezolizumab + Bevacizumab | 191 | 451 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sunitinib vs Atezolizumab + Bevacizumab: deaths from any cause | Trial comparisons |
| Sunitinib vs Atezolizumab + Bevacizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02420821
GET https://conductscience.org/api/trials/v1/NCT02420821/registered?page=2