Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
Eligible patients will receive intravenous cemiplimab every three weeks.
Conditions
This trial is treating people with cutaneous squamous cell carcinoma
Eligibility
Inclusion
- 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
Exclusion
- 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
NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Regeneron Pharmaceuticals
Scientific Title
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
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