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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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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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 | |
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[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%
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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%
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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%
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2 0.3%
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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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