NCT03737643

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,407 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Detailed description

Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique \[FIGO\] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab. The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.

Conditions

• Advanced Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
DRUG	Durvalumab	Durvalumab by intravenous infusion
DRUG	Olaparib	Olaparib tablets
DRUG	Placebo olaparib	Placebo tablets to match olaparib
DRUG	Durvalumab placebo	Matching placebo for intravenous infusion
DRUG	Carboplatin+Paclitaxel	Standard of care chemotherapy

Timeline

• Start date: 2019-01-04
• Primary completion: 2025-03-28
• Completion: 2028-03-30
• First posted: 2018-11-09
• Last updated: 2025-01-29

Locations

214 sites across 20 countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Peru, Poland, Romania, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study