Study on Avutometinib (VS-6766) and Defactinib for Treating Mesonephric Gynecologic Cancer

Inclusion Criteria

• Women aged 18 or older.
• Diagnosed with mesonephric or mesonephric-like gynecologic cancer, even if mixed with other types, as long as the mesonephric component is the main driver of the disease.
• Have measurable cancer according to specific medical criteria.
• Cancer must be persistent (still present after initial treatment) or recurrent (returned after previous treatment).
• No prior systemic therapy is required for those with metastatic or recurrent disease, but previous treatments are allowed.
• Treated brain metastases are allowed if follow-up scans show no progression. Asymptomatic brain metastases that don't need treatment are also eligible.
• HIV-positive patients on effective treatment with undetectable viral load in the last 6 months can participate.
• Patients with chronic hepatitis B must have an undetectable viral load on treatment.
• Patients with a history of hepatitis C must be treated and cured, or currently on treatment with an undetectable viral load.
• Patients with other cancers that don't interfere with this study's treatment can participate.
• Side effects from previous treatments must be resolved to baseline or mild levels, except for certain conditions like hypothyroidism and hair loss.
• Women of childbearing potential must use effective non-hormonal contraception during the study and for one month after the last dose. Recommended methods include:
  • Intrauterine device (IUD)
  • Bilateral tubal occlusion
  • Partner with a vasectomy
  • Sexual abstinence
• Must have adequate heart function and organ function as determined by specific medical tests.

Exclusion Criteria

• Patients with newly diagnosed localized cancer that can be treated with standard care or surgery are not eligible.
• Recent systemic anti-cancer therapy or surgery within specified timeframes before starting the study.
• Treatment with warfarin, unless switched to other blood thinners.
• Previous treatment with certain types of cancer drugs (MEK, RAF, or FAK inhibitors).
• Difficulty swallowing pills or absorbing medication due to certain medical conditions.
• History of specific eye conditions or high eye pressure.
• History of muscle breakdown (rhabdomyolysis).
• Allergic reactions to ingredients in Avutometinib (VS-6766) or Defactinib.
• 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.