A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

Inclusion Criteria:

1. Signed informed consent.
2. Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
3. Eastern Cooperative Oncology Group performance status of 0 to 1.
4. Measurable disease according to RECIST v1.1.
5. Availability of tumor tissue (fresh or archival) for central pathology review.
6. Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

1. Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
2. Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
3. Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
4. Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
5. Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. History of second malignancy within 3 years (with exceptions).
7. Laboratory values outside the protocol-defined range at screening.
8. Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
9. Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
10. Receipt of a live vaccine within 28 days of planned start of study therapy.
11. Current use of protocol-defined prohibited medication.
12. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
13. Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
14. Participant who is pregnant or breastfeeding.