Study on Lenvatinib and Pembrolizumab Before Surgery for Merkel Cell Carcinoma

Inclusion Criteria

• Adults aged 18 or older with a confirmed diagnosis of Merkel cell carcinoma.
• Cancer must be at stage II, III, or IV.
• Male participants must agree to use contraception during treatment and for at least 6 days after the last dose.
• Female participants must not be pregnant or breastfeeding and must agree to use contraception during treatment and for at least 30 days after the last dose if they are of childbearing potential.
• Must provide written informed consent to participate.
• Cancer must be detectable and considered removable by surgery.
• Must provide a tumor tissue sample for analysis.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must be willing and able to monitor blood pressure at home.
• Must have adequate organ function as defined in the study protocol.

Exclusion Criteria

• Women who are pregnant or have a positive pregnancy test.
• Previous treatment with certain immune or cancer therapies.
• Uncontrolled high blood pressure despite medication.
• Significant heart problems or recent heart attack or stroke.
• Bleeding disorders or risk of severe bleeding.
• High levels of protein in urine unless confirmed to be low by further testing.
• Recent cancer treatments or surgeries without adequate recovery.
• Recent live vaccinations.
• Participation in another clinical trial within the last 4 weeks.
• Immune system deficiencies or use of immunosuppressive drugs.
• Other active cancers requiring treatment in the last 3 years.
• Active brain metastases or meningitis.
• Severe allergies to pembrolizumab or its ingredients.
• Active autoimmune diseases requiring treatment in the last 2 years.
• History of lung inflammation requiring steroids.
• Active infections requiring treatment.
• History of HIV or active Hepatitis B or C infections.
• Any condition that might interfere with the study results or participation.
• Psychiatric or substance abuse disorders affecting cooperation.
• Pregnant or breastfeeding women, or those planning to conceive during the study.