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Recruiting Phase 1 NCT04428671

Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

Trial Parameters

Condition Metastatic Skin Squamous Cell Carcinoma
Sponsor Emory University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-05-15
Completion 2030-10-01
Interventions
CemiplimabRadiation TherapyTherapeutic Conventional Surgery

Brief Summary

This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. 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. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.

Eligibility Criteria

Inclusion Criteria: * Patient must have a known diagnosis of high risk cSCC defined by the following criteria: * Nodal disease with extracapsular extension (ECE) and at least one node \>= 20 mm on the surgical pathology report * In-transit metastases (ITM) defined as skin or subcutaneous metastases that are \> 2 cm from the primary lesion but are not beyond the regional nodal basin * T4 lesion for head and neck CSCC * Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves * Recurrent CSCC, defined as CSCC that arises within the area of the previously resected tumor, or at least one of the following additional features: * \>= N2b disease associated with the recurrent lesion * Nominal \>= T3 (recurrent lesion \>= 4 cm in diameter or minor bone erosion or deep invasion \> 6 mm measured from the granular layer of normal adjacent epithelium) * Poorly differentiated histology and \>= 20 mm diameter of recurrent lesion. The recurrent lesion must be docume

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