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GOG-3020 ATHENA: Ovarian Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drugs rucaparib and nivolumab are safe and will work on patients with ovarian, peritoneal and fallopian tube cancers.

Rucaparib is an approved treatment for patients with advanced ovarian cancer.

Nivolumab is a drug approved for treatment of some cancers, but not ovarian cancer.

What is the Condition Being Studied?

High-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer

Who Can Participate in the Study?

Adult females who:
- Are newly diagnosed high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has responded to chemotherapy

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
- Be randomized (like drawing numbers out of a hat) to one of four study drug options. These options include the use of a placebo, which is a sugar pill or an intravenous (IV) placebo. One of the study arms will not get a drug, using both the oral placebo and the intravenous placebo.
--rucaparib (pill) + nivolumab (IV)
--placebo (pill) + nivolumab (IV)
--rucaparib (pill) + placebo (IV)
--placebo (pill) + placebo (IV)

- Get up to 25 cycles of the study treatments
- Return for follow-up visits at 28-days and 100 days after you have completed the study treatment
- Have long-term follow-up contact that will be made every 12 weeks until you have finished participation in this study
- Be involved in this study for about 5 years

Study Details

Full Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Principal Investigator
Gynecologic Cancers Specialist
Protocol Number
IRB:PRO00100059
NCT:NCT03522246
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698