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

NCT03737643 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1407

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Advanced Ovarian Cancer

Interventions

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

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • GOG Foundation, Inc. (GOG Foundation)

    collaborator UNKNOWN

  • Myriad Genetic Laboratories, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Philipp Harter · European Network of Gynaecological Oncological Trial Groups (ENGOT)

  • Carol Aghajanian · GOG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2025-03-28
Completion
2028-03-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Peru
  • Poland
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737643 on ClinicalTrials.gov