Study on Adding Immunotherapy Drug Cemiplimab to Surgery for Advanced Skin Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06568172

Provider View

This clinical trial is exploring whether adding the immunotherapy drug cemiplimab to the usual surgery, with or without radiation, can better treat advanced squamous cell skin cancer that can be removed by surgery.

Patient Parameters

Program Overview

This study is testing if adding the immunotherapy drug cemiplimab to the standard treatment of surgery, with or without radiation, can improve outcomes for patients with advanced squamous cell skin cancer that can be surgically removed. The usual treatment involves removing the cancer through surgery, and sometimes using radiation to kill cancer cells. Cemiplimab is an immunotherapy drug that helps the immune system attack cancer cells and may prevent them from growing and spreading. While cemiplimab is approved for skin cancer that cannot be removed by surgery, it is not yet approved for cases where surgery is possible. This study aims to see if adding cemiplimab to the usual treatment is more effective than surgery alone.

Description

The main goal of this study is to find out if combining cemiplimab with surgery improves the time patients live without the cancer coming back, compared to surgery alone, in patients with advanced squamous cell skin cancer that can be removed by surgery.

Other goals include comparing how long patients live without the cancer returning, overall survival rates, and any side effects between the two treatment groups. The study will also look at how patients' quality of life changes after treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will have surgery to remove the cancer. After surgery, they may receive radiation therapy if needed. They will also have regular scans and tests to monitor their health.

  • Group 2: Patients will receive cemiplimab through an IV every 21 days for up to 4 cycles before having surgery. After surgery, they may receive radiation therapy if needed. If the cancer is not completely gone after surgery, they may receive additional cemiplimab treatments. They will also have regular scans and tests to monitor their health.

After treatment, patients will have follow-up visits at 1, 6, and 12 months after surgery, then every 3 months for 2 years, every 6 months in the third year, and annually after that.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with invasive squamous cell skin cancer or regional lymph node metastasis.
  • Cancer must be removable by surgery.
  • No distant spread of cancer to other organs.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0-2.
  • Not pregnant or nursing, with a negative pregnancy test for those of childbearing potential.
  • Adequate blood cell counts and organ function.
  • No prior systemic therapy for the study cancer.
  • No recent heart attack or severe heart disease.
  • No active infections requiring treatment.
  • No history of organ transplants or certain autoimmune diseases.
  • No history of lung disease or active tuberculosis.
  • No recent live vaccines.
  • No known allergies to the study drug or similar compounds.

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