Study on Ipilimumab and Nivolumab Before Surgery for Patients with Recurrent, High-Risk, Resectable Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of Stage IIIB-D or Stage IV melanoma that has returned and can be surgically removed.
• The cancer must have returned during or within 3 months after completing previous anti-PD1 therapy, confirmed by a biopsy.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function, including:
  • Blood health: sufficient neutrophil, platelet, and hemoglobin levels.
  • Liver health: bilirubin and liver enzyme levels within specified limits.
  • Kidney health: creatinine clearance of at least 50 mL/min.
• Women of childbearing potential must have a negative pregnancy test or be post-menopausal or surgically sterilized.
• Agree to use effective contraception if of childbearing potential or have a partner of childbearing potential.
• Provide a tumor tissue sample or agree to a new biopsy if needed.
• Have recovered from any side effects of previous treatments to a manageable level.
• Be able to understand and sign an informed consent form.

Exclusion Criteria

• Currently receiving or have recently received other investigational treatments.
• Have had systemic anti-cancer therapy within 14 days or five half-lives before starting the study treatment.
• Have had radiotherapy within 45 days before the first dose of study treatment.
• Have had major surgery within 4 weeks before starting the study drug and not fully recovered.
• Have an active infection requiring antibiotics.
• Are on systemic steroid therapy above a certain level or other immunosuppressive therapy within 7 days before registration.
• Have another active cancer that could interfere with the study.
• Have known brain metastases or disease affecting the brain lining.
• Have uncontrolled or significant health issues, such as severe heart conditions or recent strokes.
• Have uncontrolled high blood pressure.
• Have any condition that the study doctor believes would make participation unsafe or difficult.
• Have HIV with a detectable viral load unless on effective treatment with an undetectable viral load.
• Have active infections like tuberculosis, hepatitis B, or hepatitis C unless resolved or controlled.
• Have severe allergies to the study drugs or their components.
• Are taking medications that are not allowed during the study without a proper washout period.