PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Key Inclusion Criteria:

   - Confirmed diagnosis of invasive BCC

   - Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
   therapy

   - At least 1 measurable lesion

   - ≥18 years of age

   - Hepatic function, renal function, bone marrow function in defined lab-value-ranges

   - Anticipated life expectancy >12 weeks

   - Consent to provide archived tumor biopsy material (all patients)

   - Group 2: consent to undergo research biopsies

   - Group 2: must not be a candidate for radiation therapy or surgery

   - Comply with study procedures and site visits

   - Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

   - Ongoing or recent significant autoimmune disease

   - Prior treatment with specific pathway-blockers (PD-1/PD-L1)

   - Prior treatment with immune-modulating agents within 28 days before cemiplimab

   - Untreated brain metastasis that may be considered active

   - Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
   treatment with cemiplimab

   - Active infections requiring therapy, including HIV, hepatitis

   - Pneumonitis within the last 5 years

   - Cancer treatment other than radiation therapy, including investigational or standard
   of care, within 30 days prior to treatment with cemiplimab

   - Documented allergic reactions or similar to antibody treatments

   - Concurrent malignancies other than BCC, other than those with negligible risk of
   metastases or death

   - Any acute or chronic psychiatric problems

   - Having received a solid organ transplantation

   - Inability to undergo contrast radiological assessments

   - Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply