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A Single Arm Phase II Study of Cemiplimab-rwlc in Immunocompromised Patients with Unresectable Locally Recurrent and/or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab.
Primary Objective: Determine the overall response rate of Cemiplimab-rwlc in immunocompromised patients with unresectable locally recurrent and/or metastatic CSCC. Secondary Objectives: to evaluate progression-free survival, to evaluate overall survival and to evaluate acute and late toxicities. Exploratory Objectives: To identify potential biomarkers related to response to Cemiplimab-rwlc in immunocompromised patients with unresectable locally recurrent and/or metastatic CSCC and to evaluate overall response rate of underlying CLL in the CLL subset.
Cemiplimab (); REGN2810 (Cemiplimab)
> Histologically confirmed diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC)
> Prior known allergy to Cemiplimab-rwlc