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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

NCT06585410 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2026-04-22

No results posted yet for this study

Summary

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.

The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

The study is looking at:

* The side effects cemiplimab might cause
* How well cemiplimab works

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

DRUG

Cemiplimab

Administered per protocol

PROCEDURE

Standard of care

Primary surgery

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2030-05-03
Completion
2030-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT06585410 on ClinicalTrials.gov