A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Open to people ages 18 years and up

The main inclusion criteria include but are not limited to the following:

• Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
• Has not received any prior systemic therapy for their melanoma beyond surgical resection
• No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
• Is disease free at the time of providing documented consent for the study
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

The main exclusion criteria include but are not limited to the following:

• Has ocular or mucosal melanoma
• Has cancer that has spread to other parts of the body and cannot be removed with surgery
• Has heart failure within the past 6 months
• Has received prior cancer therapy or another cancer vaccine
• Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
• Has severe reaction to study medications or any of their substance used to prepare a drug
• Have not recovered from major surgery or have ongoing surgical complications