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

Inclusion Criteria:

   - Signed informed consent.

   - Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional
   disease not amenable to surgery or radiation

   - Eastern Cooperative Oncology Group performance status of 0 to 1.

   - Measurable disease according to RECIST v1.1.

   - Availability of tumor tissue (fresh or archival) for central pathology review.

   - Willingness to avoid pregnancy or fathering children based on protocol-defined
   criteria.

Exclusion Criteria:

   - Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or
   PD-L1-directed therapy.

   - Treatment with anticancer drugs or participation in another interventional clinical
   study within 21 days before the first administration of study drug.

   - 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.

   - 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.

   - Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

   - History of second malignancy within 3 years (with exceptions).

   - Laboratory values outside the protocol-defined range at screening.

   - Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.

   - Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.

   - Receipt of a live vaccine within 28 days of planned start of study therapy.

   - Current use of protocol-defined prohibited medication.

   - Known hypersensitivity to another monoclonal antibody that cannot be controlled with
   standard measures (eg, antihistamines and corticosteroids).

   - Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
   requirements.

   - Participant who is pregnant or breastfeeding.