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

Inclusion Criteria:

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

• Has surgically resected and histologically/pathologically confirmed diagnosis ofStage IIB or IIC, III, or IV cutaneous melanoma

• Has not received any prior systemic therapy for their melanoma beyond surgicalresection

• No more than 13 weeks have passed between final surgical resection that rendered theparticipant 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 controlledHIV on anti-retroviral therapy (ART)

Exclusion Criteria:

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 withsurgery

• 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 hasrequired treatment within the past 3 years

• Has severe reaction to study medications or any of their substance used to prepare adrug

• Have not recovered from major surgery or have ongoing surgical complications