Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03889912
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    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

Study Details

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

Key Dates

Start date
Apr 11, 2019
Status verified
Jan 2026
Primary completion
Nov 13, 2025
Completion
Dec 10, 2025

Study Design

Enrollment
97 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
    Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B. Note: Cohort E through G will not be opened for participation.

Primary Outcome Measure

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 [ Time Frame: From the first dose through day 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Medical Dermatology SpecialistsPhoenixArizona85006-
TCR Medical CorporationSan DiegoCalifornia92123-
Dermatology Associates of the Palm BeachesDelray BeachFlorida33445-
MetroDermAtlantaGeorgia30342-
Northeast Dermatology AssociatesBeverlyMassachusetts01915-
Rochester Dermatologic Surgery, P.C.VictorNew York14564-
Duke Cancer CenterDurhamNorth Carolina27710-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Medical Dermatology Specialists· Phoenix, AZTCR Medical Corporation· San Diego, CADermatology Associates of the Palm Beaches· Delray Beach, FLMetroDerm· Atlanta, GANortheast Dermatology Associates· Beverly, MARochester Dermatologic Surgery, P.C.· Victor, NY

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