Study on Cemiplimab for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Sponsor: University of Southern California

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04315701

Provider View

This clinical trial is testing how well the drug cemiplimab works when given before surgery to treat high-risk skin cancer that hasn't spread far, has come back, or has spread to nearby areas but can still be removed by surgery.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of cemiplimab, an immunotherapy drug, in treating patients with high-risk skin cancer that is localized, has returned, or has spread regionally but can still be surgically removed. Cemiplimab is a type of monoclonal antibody that may help the immune system attack cancer cells and prevent them from growing and spreading.

Description

The main goal of this study is to see how well cemiplimab works in shrinking skin cancer tumors before surgery. Researchers are particularly interested in the rate of partial tumor shrinkage in patients with cutaneous squamous cell carcinoma (CSCC) that can potentially be removed by surgery.

Secondary goals include estimating the complete tumor shrinkage rate, evaluating the response rate at 9 weeks, and assessing progression-free survival at 12 months. The study will also look at the safety of cemiplimab in these patients.

Exploratory goals involve examining various factors that might influence how well the treatment works, such as tumor mutational burden, PD-L1 expression, and immune cell infiltration in the tumors.

Patients will receive cemiplimab through an IV infusion every 21 days for up to 3 cycles, or 4 cycles if the cancer cannot be removed after 3 cycles. Surgery will be performed within 6 weeks after the last dose if the tumors are still removable. After treatment, patients will have follow-up visits every 3 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with cutaneous squamous cell carcinoma (CSCC).
  • Cancer must be potentially removable by surgery.
  • Must have measurable cancer.
  • Cancer must be high-risk localized, locally recurrent, or regionally advanced.
    • High-risk localized CSCC must have at least two of the following:
      • Tumor larger than 2 cm.
      • Tumor larger than 1 cm in high-risk areas like the face or hands.
      • Rapidly growing or symptomatic tumor.
      • Poorly differentiated or deep tumor.
      • Specific aggressive tumor subtypes.
      • Tumor invading beyond subcutaneous fat or involving nerves or vessels.
    • Locally recurrent CSCC must have failed previous treatments but still be removable.
    • Regionally advanced CSCC must have spread to nearby areas but still be removable.
  • ECOG performance status of 0 or 1.
  • Adequate blood cell counts and organ function.
  • Women of childbearing potential and men must use effective contraception during and after the study.
  • Must understand and agree to the study procedures and sign informed consent.

Exclusion Criteria

  • Cancer that has spread to distant organs and cannot be removed.
  • Previous treatment with cemiplimab or similar drugs.
  • Recent treatment with other immune-modulating agents.
  • Currently receiving other cancer treatments or investigational drugs.
  • Recent radiation or investigational treatments.
  • Recent use of high-dose corticosteroids.
  • Recent major surgery without full recovery.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • History of other cancers in the last 5 years, except certain skin cancers or localized tumors.
  • Allergic reactions to similar drugs.
  • Uncontrolled illnesses that could interfere with the study.
  • Positive pregnancy test, active pregnancy, or breastfeeding.
  • History of organ or bone marrow transplant.

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