Study on IFx-Hu2.0 and Pembrolizumab for Advanced or Metastatic Merkel Cell Carcinoma

Inclusion Criteria

• Must be 18 years or older.
• Have a life expectancy of at least six months.
• Be in relatively good health, with a performance status score of less than 2.
• Have advanced or metastatic Merkel Cell Carcinoma that cannot be removed by surgery.
  • Must have at least one tumor that can be injected and is 3 mm or larger.
  • Must have measurable disease according to specific medical criteria.
• Must not have received prior treatment with checkpoint inhibitors like pembrolizumab or similar drugs.
• Must provide a tumor sample for analysis, either from a previous biopsy or a new one if needed.
• Must have adequate blood, liver, and kidney function based on medical tests.

Exclusion Criteria

• Have uncontrolled health issues such as ongoing infections, heart problems, or psychiatric conditions that could interfere with the study.
• Have active brain cancer, unless it has been treated and stable for at least four weeks before starting the study.
• Have resectable Merkel Cell Carcinoma that can be surgically removed.
• Have received prior systemic chemotherapy.
• Be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study.
• Have an active autoimmune disease, except for certain conditions like type I diabetes or skin disorders that do not require systemic treatment.
• Require treatment with high doses of steroids or other immunosuppressive drugs within 14 days before starting the study, except for inhaled or topical steroids.