A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Running, not enrolling · Phase 2

Conditions studied: Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer

In brief

This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key facts

Study ID

NCT04315701

Run by

University of Southern California

People needed

35

Starts

2020-06-17

Expected to finish

2027-12-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, cutaneous squamous cell carcinoma
• Patients must have disease that is deemed potentially resectable, at the time of the start of study, by the treating investigator. The decision to perform surgery on patients must be based on good clinical judgment. Eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed potentially resectable, resulting in free surgical margins
• Patients must have measurable disease
• Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC. The criteria specific to each of these populations is listed below
• For patients with high-risk localized CSCC, at least two of the following clinical or pathologic high-risk features must be present to be eligible:
• Clinical risk factors
• Any tumor size > 2.0 cm in diameter
• Tumors > 1.0 cm in high risk locations, including "mask areas" (central face, eyelids, eyebrow, nose, lips [cutaneous], periorbital, chin, mandible, preauricular and postauricular skin/sulci, genitalia, hands, feet, cheek, forehead, scalp, neck and pretibial)
• Any rapidly growing and/or symptomatic tumor
• Pathologic risk factors
• Poorly differentiated histology
• Depth > 6 mm in thickness
• Acantholytic / adenoid, adenosquamous, desmoplastic, or metaplastic / carcinosarcomatous histologic subtypes
• Invasion beyond subcutaneous fat
• Perineural, lymphatic, or vascular involvement
• Patients with locally recurrent CSCC, that failed prior surgery, radiation or systemic therapy, are eligible, as long as they have measurable disease and are deemed potentially resectable by the treating investigator
• Patients with regionally advanced CSCC, including in-transit, cutaneous, subcutaneous or lymph node metastases are eligible, as long as they have measurable disease and are deemed potentially resectable by the treating investigator
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Absolute neutrophil count >= 1,000 /mcL
• Absolute lymphocyte count >= 500 / mcL
• Hemoglobin >= 8.0 g/dL
• Platelets >= 75,000/mcl
• Total bilirubin =< 1.5 x institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 3 x institutional upper limit of normal
• Creatinine =< 1.8 mg/dl

You may not qualify if…

• Metastatic disease that is unresectable. Patients with visceral metastases are not eligible. Regionally advanced disease, including in-transit, cutaneous, subcutaneous, or nodal metastases are allowed, if deemed potentially resectable by the investigator
• Prior treatment with cemiplimab or any other agent that blocks the PD-1 or PD-L1 pathway
• Prior treatment with other immune modulating agents within fewer than 4 weeks, prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB, OX-40, therapeutic vaccines, or cytokine therapies
• Patients must not be receiving other concomitant biologic therapy, hormonal therapy, chemotherapy, other anti-cancer therapy or any other investigational agents while on this protocol
• Radiation therapy, non-cytotoxic agents or investigational agents in the 4 weeks prior to registration
• Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first dose of cemiplimab
• Any major surgery within 14 days prior to the first dose of cemiplimab. Patients must have recovered from any major complications before registration
• Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
• History of other prior malignancy in the last five years, with the exception of: adequately treated non-melanoma skin cancers (including multiple primary skin cancers), adequately treated in situ cancer, and other local tumors considered cured by local treatment (including melanoma)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab or any other PD-1 or PD-L1 inhibitor
• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements
• Positive pregnancy test, active pregnancy or nursing / breast-feeding, due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• History solid organ or bone marrow transplantation

Where it is running

• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• University of Nebraska — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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