A Phase III Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab, and Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Full Title

A Phase III Randomized, 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) (GOG 3025) (WIRB)

Purpose

This study is comparing the effectiveness of three different treatment regimens for women newly diagnosed with stage III or IV ovarian cancer. Patients will be randomly assigned to one of these treatments:

  • Platinum-based chemotherapy plus bevacizumab and placebo (inactive treatment) followed by maintenance bevacizumab and placebo.
  • Platinum-based chemotherapy plus bevacizumab and durvalumab, followed by maintenance bevacizumab, durvalumab, and placebo.
  • Platinum-based chemotherapy plus bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab, and olaparib.

Chemotherapy, bevacizumab, and durvalumab are given intravenously (by vein) and olaparib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed ovarian cancer that has been or can be surgically removed.
  • Patients may not have previously received PARP inhibitor treatment (such as olaparib) or immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Carol Aghajanian at 646-888-4225.

Protocol

19-053

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators