Trial · NCT03038100
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03038100, Phase 3, Completed, Hoffmann-La Roche; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT03038100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03038100
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT03038100
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,301 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Interventions
- Paclitaxel, Carboplatin, Atezolizumab, Bevacizumab, Atezolizumab Placebo
- First posted
- 2017-01-31
- Last updated
- 2023-02-17
- Other registries' IDs
- eudract:2016-003472-52
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first. |
| Primary | PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation | From randomization until disease progression or death from any cause (up to approximately 55 months) | Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first. |
| Primary | Overall Survival - ITT Population | From randomization up to death from any cause (up to approximately 59 months) | Overall Survival (OS) is defined as the time from randomization to death from any cause. |
| Primary | Overall Survival - PD-L1-Positive Subpopulation | From randomization up to death from any cause (up to approximately 59 months) | Overall Survival (OS) is defined as the time from randomization to death from any cause. |
| Secondary | Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery. |
| Secondary | Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery. |
| Secondary | Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population | From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months) | DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery. |
| Secondary | Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population | From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months) | DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery. |
| Secondary | Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group | From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days. | Clinically-meaningful improvement defined as a \>=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31). |
| Secondary | Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group | From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days. | Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a \>=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation | From randomization until disease progression or death from any cause (up to approximately 55 months) | PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. | Months | MEDIAN |
| PRIMARY | Overall Survival - ITT Population | From randomization up to death from any cause (up to approximately 59 months) | Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received. | Months | MEDIAN |
| PRIMARY | Overall Survival - PD-L1-Positive Subpopulation | From randomization up to death from any cause (up to approximately 59 months) | PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population | From randomization until disease progression or death from any cause (up to approximately 55 months) | Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population | From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months) | Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Months | MEDIAN |
| SECONDARY | Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population | From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months) | Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The PD-L1-positive subpopulation (defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization) who underwent primary tumor-reductive surgery. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group | From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days. | Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group | From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days. | PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group613
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 18.37 | 95% Confidence Interval 17.22 to 19.75 | Months | |
| Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 19.48 | 95% Confidence Interval 18.14 to 20.76 | Months | |
| PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 18.50 | 95% Confidence Interval 16.62 to 21.36 | Months | |
| PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 20.83 | 95% Confidence Interval 19.06 to 24.21 | Months | |
| Overall Survival - ITT Population | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 46.59 | 95% Confidence Interval 45.31 to 49.74 | Months | |
| Overall Survival - ITT Population | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 50.53 | 95% Confidence Interval 46.26 to NA | Months | |
| Overall Survival - PD-L1-Positive Subpopulation | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 49.15 | 95% Confidence Interval 45.54 to NA | Months | |
| Overall Survival - PD-L1-Positive Subpopulation | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 88.7 | Percentage of participants | ||
| Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 92.8 | Percentage of participants |
1 to 10 of 613Source ClinicalTrials.gov
See all 613 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 650 | |
| Overall Study | STARTED | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 651 | |
| Overall Study | COMPLETED | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 0 | |
| Overall Study | COMPLETED | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 650 | |
| Overall Study | NOT COMPLETED | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 651 |
Source ClinicalTrials.gov
Adverse events764
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 | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 284 | 642 | 468 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 266 | 644 | 440 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 69 | 642 | 197 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 76 | 644 | 243 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 195 | 642 | 477 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 197 | 644 | 507 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 137 | 642 | 278 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 134 | 644 | 275 |
| other | HYPERTHYROIDISM | Endocrine disorders | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 51 | 642 | 56 |
| other | HYPERTHYROIDISM | Endocrine disorders | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 23 | 644 | 26 |
1 to 10 of 764Source ClinicalTrials.gov
See all 764 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 272 | 651 |
| Total, all-cause mortality | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 289 | 650 |
| Total, other adverse events | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 637 | 642 |
| Total, other adverse events | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 637 | 644 |
| Total, serious adverse events | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 304 | 642 |
| Total, serious adverse events | Placebo With Paclitaxel, Carboplatin and Bevacizumab | 215 | 644 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab vs Placebo With Paclitaxel, Carboplatin and Bevacizumab: deaths from any cause | Trial comparisons |
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab vs Placebo With Paclitaxel, Carboplatin and 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/NCT03038100
GET https://conductscience.org/api/trials/v1/NCT03038100/results?page=2