Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
- Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
- At least 1 lesion that is measurable by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ, bone marrow function, and hepatic function as defined in the protocol
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
- Distant metastatic disease (M1), visceral and/or distant nodal
- Prior radiation therapy for CSCC
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
- Active tuberculosis
Trial Phase Phase II
Trial Type Treatment
Regeneron Pharmaceuticals, Inc.
- Primary ID R2810-ONC-1901
- Secondary IDs NCI-2020-01325, 2019-003007-35
- Clinicaltrials.gov ID NCT04154943