Trials / Completed
CompletedNCT03038100
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
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,301 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle |
| DRUG | Carboplatin | Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter\*minute (mg/mL\*min) on Day 1 of each 21-day cycle for a total of 6 cycles |
| DRUG | Atezolizumab | Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle |
| DRUG | Bevacizumab | Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms |
| DRUG | Atezolizumab Placebo | Placebo matching to atezolizumab on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2017-03-08
- Primary completion
- 2022-02-08
- Completion
- 2022-08-12
- First posted
- 2017-01-31
- Last updated
- 2023-02-17
- Results posted
- 2023-02-17
Locations
268 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Norway, Poland, Russia, South Korea, Spain, Sweden, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03038100. Inclusion in this directory is not an endorsement.