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.

What is the Condition Being Studied?

Cáncer de ovario

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.

Grupo etario
Adultos

What is Involved?

If you choose to join this study, you will go through a screening period to make sure you are eligible. Durante este período, usted:

  • Have a tumor biopsy
  • Hacer un examen físico
  • Hacer extracciones de sangre y dar muestras de orina
  • 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

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
Especialista en oncología ginecológica
Protocol Number
IRB: PRO00116690
NCT: NCT06619236
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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