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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502747-35-00

Acronym

DUO-O/D081RC00001

Enrollment

825

Registered

2024-10-04

Start date

2019-02-18

Completion date

Unknown

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fallopian or primary peritoneal cancer, Newly diagnosed advanced (FIGO stage III-IV) high grade epithelial ovarian

Brief summary

Progression Free Survival (PFS) is defined as the time from randomisation to the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from assigned therapy or receives another anticancer therapy prior to progression.

Detailed description

Progression Free Survival (PFS), Overall Survival (OS), Second Progression (PFS2), Objective Response Rate (ORR), Duration of response (DoR), Time to first subsequent therapy (TFST), Time to second subsequent therapy (TSST), Time to discontinuation or death (TDT), Pathological complete response (pCR), Health related Quality of Life (HRQoL), Pharmacokinetic and Immunogenicity

Interventions

DRUGINFLIXIMAB

DRUGLynparza 150 mg film-coated tablets

DRUGSodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion (not authorised)

DRUGPlacebo film-coated tablet (Not Authorised)

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGMYCOPHENOLATE MOFETIL

DRUGLynparza 100 mg film-coated tablets

DRUGBEVACIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) is defined as the time from randomisation to the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from assigned therapy or receives another anticancer therapy prior to progression.	—

Secondary

Measure	Time frame
Progression Free Survival (PFS), Overall Survival (OS), Second Progression (PFS2), Objective Response Rate (ORR), Duration of response (DoR), Time to first subsequent therapy (TFST), Time to second subsequent therapy (TSST), Time to discontinuation or death (TDT), Pathological complete response (pCR), Health related Quality of Life (HRQoL), Pharmacokinetic and Immunogenicity	—

Countries

Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026