This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
Histologically proven LGSOC (ovarian, fallopian, peritoneal)
Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
Co-existing high-grade serous ovarian cancer or mixed histology.
Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
History of prior malignancy with recurrence <3 years from the time of enrollment.
Verastem, Inc.
Lead sponsor
GOG Foundation
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Australia New Zealand Gynaecological Oncology Group
Collaborator
Korean Gynecologic Oncology Group
Collaborator