GOG-3107 RAINFOL Rinatabart versus Investigator's Choice (Ovarian Cancer)

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.

Who Can Participate?

Eligibility

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.

Age Range

18-64

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Phase 3 Randomized, Open-label Study of RinatabartSesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer

Principal Investigator

Angeles
Secord

Protocol Number

PRO00116690

NCT ID

NCT06619236

Phase

III

Enrollment Status

Open to Enrollment