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

NCT03889912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-01-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2025-11-13
Completion
2025-12-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889912 on ClinicalTrials.gov