Summary

Eligibility
for females ages 18-130 (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Edwin Alvarez (ucsf)

Description

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.

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).

Details

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.

Keywords

Advanced Ovarian Cancer, Ovarian neoplasms, Ovarian Epithelial Carcinoma, Paclitaxel, Bevacizumab, Carboplatin, Durvalumab, Olaparib, Monoclonal Antibodies, Carboplatin+Paclitaxel

Eligibility

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    San Francisco California 94158 United States
  • Research Site
    Foothill Ranch California 92610 United States
  • Research Site
    Orange California 92868-3298 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03737643
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1407 people participating
Last Updated