Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2021-07-12
Target enrollment:
Participant gender:
Summary
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