drugset / Trial / NCT02891824
ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |