CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,301 enrolled
Drug / intervention
Paclitaxel +4 moredrug
Likely dose
Paclitaxel 175 mg/m² IV on Day 1 of each 21-day cycle; Carboplatin AUC 6 mg/mL·min IV on Day 1 of each 21-day cycle for 6 cycles; Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle; Bevacizumab 15 mg/kg IV per scheduleAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • ✓ECOG performance status 0, 1, or 2
  • ✓Life expectancy greater than 12 weeks
  • ✓Availability of tumor specimen (FFPE blocks preferred or ≥20 unstained slides) for biomarker testing
Key exclusion· 17
  • ✕Borderline epithelial ovarian tumors
  • ✕Recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with surgery alone (e.g., Stage IA or IB)
  • ✕Non-epithelial ovarian tumors (germ cell, sex cord stromal)
  • ✕Prior radiotherapy to abdomen or pelvis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03038100
NCT03038100Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Jan 31, 2017·Updated Feb 17, 2023

In Brief

A Phase 3 clinical trial evaluating Paclitaxel, Carboplatin, and 3 other interventions for Ovarian Cancer and 2 related conditions. Completed, enrolled 1,301 participants across 268 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
CountriesAustralia, Austria, Belgium, Brazil, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Norway, Poland, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), United States
CollaboratorsGOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartMar 8, 2017
Primary CompletionFeb 8, 2022
Study CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.4 years ago

Interventions

Paclitaxeldrug

Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle

Carboplatindrug

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

Atezolizumabdrug

Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle

Bevacizumabdrug

Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms

Atezolizumab Placebodrug

Placebo matching to atezolizumab on Day 1 of each 21-day cycle