NCT03889912

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

A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cutaneous Squamous Cell Carcinoma
• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	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

Timeline

• Start date: 2019-04-11
• Primary completion: 2025-11-13
• Completion: 2025-12-10
• First posted: 2019-03-26
• Last updated: 2026-01-21

Locations

18 sites across 3 countries: United States, Australia, Netherlands

Regulatory

• FDA-regulated drug study