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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1301

Last updated 2023-02-17

Study results available
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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

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

Sponsors & Collaborators

  • GOG Foundation

    collaborator NETWORK

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2022-02-08
Completion
2022-08-12
FDA Drug
Yes

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)

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038100 on ClinicalTrials.gov