Study on Avutometinib, Defactinib, and Letrozole for Low-Grade Serous Ovarian Cancer

Inclusion Criteria

• Women aged 18 or older.
• Diagnosed with low-grade serous ovarian cancer (LGSOC) confirmed by a tissue biopsy.
• Not suitable for primary surgery or have remaining measurable disease after surgery.
• Have at least one tumor that can be measured by scans.
• Good overall health with an ECOG performance status of 0 or 1. Patients with a status of 2 may be included if it's due to cancer.
• Treated brain metastases are allowed if stable after treatment. Asymptomatic brain metastases not needing treatment are also allowed.
• HIV-positive patients on effective treatment with undetectable viral load can participate.
• Patients with controlled hepatitis B or cured hepatitis C are eligible.
• Women of childbearing potential must use effective contraception during the study and for one month after the last dose.
• Adequate heart function with a left ventricular ejection fraction of 50% or higher.
• Normal QTc interval on an ECG.
• Adequate blood, liver, and kidney function as determined by specific tests.

Exclusion Criteria

• Suitable for primary debulking surgery unless measurable disease remains after surgery.
• Previous systemic treatment for LGSOC or serous borderline disease.
• Recent major or minor surgery or radiation therapy close to the start of the study.
• Taking warfarin (can switch to other blood thinners).
• Unable to swallow pills or have absorption issues due to certain medical conditions.
• Symptomatic brain metastases needing treatment.
• Eye conditions that increase the risk of retinal vein occlusion or other serious eye issues.
• History of muscle breakdown (rhabdomyolysis).
• Allergic to any ingredients in the study drugs.
• Breastfeeding women.
• Any medical condition that poses a high risk for treatment complications.
• Use of certain medications, supplements, or foods that may interact with the study drugs within 14 days before starting the study.