GOG-3107 RAINFOL Rinatabart versus Investigator's Choice (Ovarian Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called Rina-S (the study drug) is a safe and effective option for ovarian cancer that is not improving with standard treatments.
Ovarian Cancer
Who Can Participate in the Study?
Adults ages 18-64 who:
- Are diagnosed with ovarian cancer
- Have already received at least 1 but not more than 4 lines of previous therapy
- Have disease that is not responding adequately to treatment
- Have known or suspected deleterious germline or somatic BRCA mutations
For more information, contact the study team at patricia.vaudo@duke.edu.
What is Involved?
If you choose to join this study, you will go through a screening period to make sure you are eligible. During this period, you will:
- Have a tumor biopsy
- Have a physical exam
- Have blood draws and give urine samples
- Have heart scans (echocardiogram and EKG)
- Have imaging done (CT and/or MRI)
If you are eligible based on screening, you will proceed to the study dosing period. During this period, you will get a random assignment (50:50 chance, like a coin flip) to either get the study drug or get treatment with a standard chemotherapy regimen.
If you are assigned to take the study drug, you will get the study drug as an intravenous (IV) infusion once every 3 weeks.
If you are assigned to get a standard chemotherapy treatment, the study doctor will decide what available treatment is most appropriate for you. The study doctor will choose from 4 options:
- Paclitaxel, given as an IV infusion on Days 1, 8, and 15 every 4 weeks
- Topotecan, given as an IV infusion on Days 1, 8 and 15 every 4 weeks, or as an IV infusion on Days 1-5 every 3 weeks (the study doctor will decide on the dosing schedule)
- Pegylated liposomal doxorubicin, given as an IV infusion once every 4 weeks
- Gemcitabine, given as an IV infusion on Days 1, 8, and 15 every 4 weeks
You will take your assigned study regimen for as long as the study doctor believes that you are getting a benefit. After you stop your regimen, we will schedule you to come in for follow-up visits to see how you are doing.
Study Details
