Clinical Trials

Inclusion Criteria:

• For Japan only, men and women ≥21 years old
• Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only; or
• Primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC.
• Lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
• High risk CSCC, as defined in the protocol.
• Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization.
• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
• Adequate hepatic, renal, and bone marrow function as defined in the protocol.

Exclusion Criteria:

• Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol.
• Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol.
• Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
• Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary).
• Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary:
  • vitiligo;
  • childhood asthma that has resolved;
  • type 1 diabetes;
  • residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
• Has had prior systemic anti-cancer immunotherapy for CSCC.

Note: Other protocol defined Inclusion/Exclusion Criteria apply.

Eligibility last updated 5/24/22. Questions regarding updates should be directed to the study team contact.