Study #2018-0933
A Phase 1 Study Of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, For Patients With Recurrent Cutaneous Squamous Cell Carcinoma (CSCC)
MD Anderson Study Status
Enrolling
Treatment Agent
Cemiplimab
Description
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
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
Study phase:
I
Physician name:
Michael Migden
Department:
Dermatology
For general questions about clinical trials:
1-877-632-6789
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