A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

Summary

Objectives

This international, randomized, open-label, Phase 3 study will compare the
investigational combination of avutometinib plus defactinib versus Investigator's Choice
of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior
platinum-based therapy. Avutometinib and defactinib are both a type of drug called a
kinase inhibitor. Kinase inhibitors block cancer cell growth. The study will compare the
progression-free survival (PFS) of the combination of avutometinib plus defactinib versus
ICT. The study will also evaluate the effect of the combination on safety, overall
survival, other efficacy endpoints, and health-related quality of life and disease
related symptoms. The study is being conducted by gynecological cancer specialists.
Patients who are eligible and agree to participate in this study will be treated with
either a combination of avutometinib with defactinib, or with one of five standard of
care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with
subsequent follow up appointments. Patients who originally received one of the standard
of care treatments who are determined to have progressive disease may be eligible to
crossover to receive the investigational combination avutometinib plus
defactinib.Avutometinib and defactinib are investigational drugs that have not been
approved by the U.S. Food and Drug Administration (FDA)