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

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Neoplasms

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle
• Carboplatin — DRUG
  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
• Atezolizumab — DRUG
  Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
• Bevacizumab — DRUG
  Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
• Atezolizumab Placebo — DRUG
  Placebo matching to atezolizumab on Day 1 of each 21-day cycle

Study Details

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.

Key Dates

Start date

Mar 8, 2017

Status verified

Feb 2023

Primary completion

Feb 8, 2022

Completion

Aug 12, 2022

Study Design

Enrollment

1,301 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
  Participants in the primary tumor-reductive surgery group will receive 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 will receive 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 will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
• Placebo Comparator: Placebo With Paclitaxel, Carboplatin and Bevacizumab
  Participants in the primary tumor-reductive surgery group will receive 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 will receive 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 will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Primary Outcome Measure

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 [ Time Frame: From randomization until disease progression or death from any cause (up to approximately 55 months) ]

Locations (127)

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