Durvalumab treatment in combination with Chemotherapy and Bevacizumab, followed by maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer patients - DUO-O

Study identifier:D081RC00001

ClinicalTrials.gov identifier:NCT03737643

EudraCT identifier:2017-004632-11

CTIS identifier:2022-502747-35-00

Recruitment Complete

Official Title

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).

Medical condition

Advanced Ovarian cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Bevacizumab, Durvalumab, Olaparib, Placebo olaparib, Durvalumab placebo, Carboplatin+Paclitaxel

Sex

Female

Actual Enrollment

1407

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 04 Jan 2019
Estimated Primary Completion Date: 28 Mar 2025
Estimated Study Completion Date: 30 Mar 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

European Network of Gynaecological Oncology Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc.

Inclusion and exclusion criteria