A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma

Exclusion Criteria

• •1. Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
• •2. Is currently participating in a study of an investigational agent or using an investigational device
• •3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
• •4. Has undergone major surgery within 30 days of Study Day 1
• •5. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• •6. Has known active central nervous system (CNS) metastases
• •7. Has carcinomatous meningitis
• •8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study
• •9. Has an active infection requiring systemic therapy
• •10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected)
• •11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment