Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

Clinical Trial Title

Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

National Clinical Trial Number:

NCT06568172

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Protocol Description:

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  1. Type of Skin Cancer
    You must have a specific kind of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has either spread to nearby lymph nodes or shows signs of traveling through the skin.
  2. Stage of the Cancer
    Your cancer must be in a serious stage (stage III or IV), but it cannot have spread to far-away organs.
  3. Where the Cancer Started
    The cancer needs to be on the skin of the head, neck, eyelid, or another skin area. If it's inside the body (like in the mouth or nose), it doesn’t count.
  4. Able to Have Surgery
    The tumor must be able to be completely removed by surgery with the goal of curing it. If the cancer has grown too deep into the bones at the base of the skull, you can’t join the study.
  5. Overall Health & Age
    You must be 18 or older, not pregnant, and well enough to take part (able to walk around and take care of yourself at least most of the day). Your lab tests like blood counts and kidney function also have to meet minimum levels.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Michael Jelinek, MD

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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