This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810). The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks. The study is also looking at several other research questions, including: * What side effects may happen from taking the study drug * To see effect of cemiplimab on the tumor * How much study drug is in the blood at different times
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery
Medical Dermatology Specialists
Phoenix, Arizona, United States
TCR Medical Corporation
San Diego, California, United States
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, United States
MetroDerm
Atlanta, Georgia, United States
Northeast Dermatology Associates
Beverly, Massachusetts, United States
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Princess Alexandra Hospital
Brisbane, Queensland, Australia
...and 8 more locations
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Time frame: From the first dose through day 28
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Time frame: From the first dose to 90 days after the last dose
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Time frame: From the first dose up to 90 days after the last dose
The incidence and severity of injection site reactions (ISRs)
Time frame: From the first dose to 90 days after the last dose
Objective response rate (ORR) of index lesion
Determined by the investigator using the modified World Health Organization (WHO) criteria
Time frame: At baseline and at Week 13
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Time frame: At time of surgery
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Time frame: At time of surgery
Cemiplimab concentration in serum over time
Time frame: From the first dose up to 90 days after the last dose
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Time frame: Up to 90 days after last dose
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.
Time frame: Up to 90 days after last dose
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