Ensayos clínicos

Inclusion Criteria: 

• Signed informed consent. 
• Diagnosis of MCC with distant metastatic disease as a component of tumor burden and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy. 
• 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 programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (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 in 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 90 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 (e.g., antihistamines and corticosteroids).
• Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements. 
• Participant who is pregnant or breastfeeding.