Phase 3 Study Comparing Avutometinib Plus Defactinib Versus Investigators Choice of Treatment in Women with Recurrent Low-Grade Serous Ovarian Cancer

What this Trial Is About

The trial investigates the safety and effectiveness of a combination of two investigational kinase inhibitor drugs, avutometinib and defactinib, compared to standard treatments chosen by doctors for women with recurrent low-grade serous ovarian cancer LGSOC who have not responded to prior platinum-based therapy. The goal is to improve progression-free survival and evaluate overall survival, safety, quality of life, and disease symptoms in this patient group. Participants will receive either the combination of avutometinib taken orally twice weekly and defactinib taken orally twice daily on a 21 days on, 7 days off schedule per 28-day cycle, or one of four standard treatments selected by their doctor. These standard treatments include intravenous pegylated liposomal doxorubicin, intravenous paclitaxel, or oral anastrozole or letrozole, each given according to specified doses and schedules. Patients initially receiving standard treatments who experience disease progression may switch to the investigational combination. During the study, participants will have regular follow-up visits to monitor their health, side effects, and disease progression over up to 24 months for progression-free survival and up to 5 years for overall survival. Researchers will assess tumor response, adverse events, drug levels in blood, and quality of life using validated questionnaires. The study involves randomized assignment to treatment groups and includes ongoing assessments to understand the impact of therapies on cancer control and patient well-being.

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