Pilot Study of Neoadjuvant/Adjuvant Cemiplimab for High Risk Cutaneous Squamous Cell Carcinoma
Emory University
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.
Description
PRIMARY OBJECTIVE: I. To establish the pathologic response rate of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma (cSCC). SECONDARY OBJECTIVES: I. To document the local recurrence rate of high-risk cSCC treated with adjuvant cemiplimab. II. To document the systemic recurrence rate of high-risk cSCC treated with adjuvant cemiplimab. III. To document the 6-month, 12-month, 2-year overall survival (OS), recurrence-free survival (RFS) for patients with high risk cSCC. TERTIARY/EXPLORATORY OBJECTIVE: I. To evaluate the immune profile of fresh tumor tissue, blood in patients with…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 prev…
Interventions
- BiologicalCemiplimab
Given IV
- RadiationRadiation Therapy
Undergo standard of care radiation therapy
- ProcedureTherapeutic Conventional Surgery
Undergo standard of care surgery
Location
- Emory University/Winship Cancer InstituteAtlanta, Georgia