drugset / Trial / NCT02891824

ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab

NCT02891824

Phase 3 Completed 614 enrolled ARCAGY/ GINECO GROUP Hoffmann-La Roche · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval \> 6 months).

Timeline

Start
2016-09-22
Primary completion
2021-10-15
Completion
2024-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 800 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Gemcitabine Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous

Indications