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 (IMagyn050)
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ClinicalTrials.gov Identifier: NCT03038100 |
Recruitment Status :
Completed
First Posted : January 31, 2017
Results First Posted : February 17, 2023
Last Update Posted : February 17, 2023
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Sponsor:
Hoffmann-La Roche
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms |
Interventions |
Drug: Paclitaxel Drug: Carboplatin Drug: Atezolizumab Drug: Bevacizumab Drug: Atezolizumab Placebo |
Enrollment | 1301 |
Participant Flow
Recruitment Details | The study is considered "Completed" because all pre-planned study activities and analyses have been performed. |
Pre-assignment Details |
Arm/Group Title | Placebo With Paclitaxel, Carboplatin and Bevacizumab | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab |
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Arm/Group Description | Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles. | Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles. |
Period Title: Overall Study | ||
Started | 650 | 651 |
Completed | 0 | 0 |
Not Completed | 650 | 651 |
Reason Not Completed | ||
Death | 289 | 272 |
Lost to Follow-up | 9 | 10 |
Protocol Deviation | 1 | 4 |
Withdrawal by Subject | 45 | 51 |
Study Terminated By Sponsor | 305 | 311 |
Physician Decision | 1 | 3 |
Baseline Characteristics
Arm/Group Title | Placebo With Paclitaxel, Carboplatin and Bevacizumab | Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | Total | |
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Arm/Group Description | Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles. | Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles. | Total of all reporting groups | |
Overall Number of Baseline Participants | 650 | 651 | 1301 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 650 participants | 651 participants | 1301 participants | |
59.3 (10.7) | 58.9 (10.5) | 59.1 (10.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 650 participants | 651 participants | 1301 participants | |
Female |
650 100.0%
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651 100.0%
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1301 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 650 participants | 651 participants | 1301 participants | |
Hispanic or Latino |
38 5.8%
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39 6.0%
|
77 5.9%
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Not Hispanic or Latino |
598 92.0%
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589 90.5%
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1187 91.2%
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Unknown or Not Reported |
14 2.2%
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23 3.5%
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37 2.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 650 participants | 651 participants | 1301 participants | |
American Indian or Alaska Native |
6 0.9%
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5 0.8%
|
11 0.8%
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|
Asian |
155 23.8%
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150 23.0%
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305 23.4%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
2 0.3%
|
2 0.2%
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Black or African American |
13 2.0%
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8 1.2%
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21 1.6%
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White |
461 70.9%
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464 71.3%
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925 71.1%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
15 2.3%
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22 3.4%
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37 2.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03038100 |
Other Study ID Numbers: |
YO39523 2016-003472-52 ( EudraCT Number ) |
First Submitted: | January 30, 2017 |
First Posted: | January 31, 2017 |
Results First Submitted: | January 9, 2023 |
Results First Posted: | February 17, 2023 |
Last Update Posted: | February 17, 2023 |