A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

UVA Tracking #
HSR230442
Principal Investigator
Kari E Ring
Contact
Contact Phone
Official Trial Title
A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Study Description

The University of Virginia seeks adults ages 18 and over with Advanced Ovarian, Fallopian, or Peritoneal Cancer for a research study. You will be eligible if you have Low-Grade Serous Ovarian Cancer or LGSOC (ovarian, fallopian, peritoneal).

The primary objective of this study is to compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs. Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC. The study drugs, called avutometinib and defactinib, are both a type of drug called a kinase inhibitor. Kinase inhibitors block cancer cell growth.
You may be eligible for this study if you have:
• Histologically proven LGSOC (ovarian, fallopian, peritoneal)
• Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
• Measurable disease according to RECIST v1.1.
• An Eastern Cooperative Group (ECOG) performance status = 1.

This study involves an ophthalmology exam, electrocardiogram (ECG), blood sampling, and CT scans. The study drug will be taken by mouth.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Study Details | A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer | ClinicalTrials.gov

Compensation

No Compensation