Intralesional Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
Trial ID or NCT#
Status
Purpose
The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC) The secondary objectives of this study are: - To describe the objective response rate (ORR) in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC, according to modified World Health Organization (WHO) criteria - To describe the pathologic complete response (CR) rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC - To describe the major pathologic response rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC - To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with CSCC or BCC - To assess the immunogenicity of cemiplimab in patients with CSCC or BCC - To establish a recommended dose of intralesional cemiplimab for further study in patients with CSCC or BCC
Official Title
A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
Eligibility Criteria
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Alexander Ayon Valencia
650-498-5185
View on ClinicalTrials.gov