Last updated on July 2019

Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma


Brief description of study

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC.

The secondary objectives of this study are:

  • To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified World Health Organization (WHO) criteria
  • To describe the pathologic complete response (CR) rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To describe the major pathologic response rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To assess the immunogenicity of cemiplimab in patients with recurrent CSCC
  • To establish a recommended dose of intralesional cemiplimab for further study in patients with recurrent CSCC

Clinical Study Identifier: NCT03889912

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