A Phase II Study of Cemiplimab Given Before and After Surgery for Cutaneous Squamous Cell Carcinoma

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Full Title

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Purpose

Cemiplimab is an immunotherapy used to treat a kind of skin cancer called cutaneous squamous cell carcinoma. It is approved by the U.S. Food and Drug Administration to treat cutaneous squamous cell carcinoma that has spread (metastasized) or cannot be cured with surgery or radiation therapy. In this study, researchers want to see if cemiplimab can shrink cutaneous squamous cell carcinoma when given before surgery and if it can reduce the risk of the cancer coming back when it is also given after surgery.

Everyone in this study will receive cemiplimab before surgery. After surgery, patients will receive more cemiplimab, radiation therapy, or no treatment, depending on the outcome of the surgery. Cemiplimab works by blocking a protein called PD-1 that normally acts as a brake on the immune system. Blocking this protein is like releasing the brake, enabling the immune system to target cancer cells and destroy them. Cemiplimab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II-IV non-metastatic squamous cell carcinoma that is scheduled to be surgically removed.
  • Patients may not have received prior treatment for their cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Lara Dunn at 646-608-3787.

Protocol

20-549

Phase

II

Disease Status

Newly Diagnosed

Investigator