A Phase III Study of Cemiplimab Immunotherapy versus Placebo to Reduce the Risk of Cancer Recurrence after Surgery and Radiation Therapy in Patients with High-Risk Cutaneous Squamous Cell Carcinoma

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Full Title

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (WIRB)

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 prevent cutaneous squamous cell cancer from returning after surgery and radiation therapy in patients with high-risk disease.

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.

Patients in this study will be randomly assigned to receive cemiplimab or a placebo (inactive drug). Patients in either group will be able to receive cemiplimab in the second part of the study if their cancer continues to grow. 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 cutaneous squamous cell carcinoma that has been treated with surgery and radiation therapy and has a high risk of coming back.
  • Patients may not have received prior immunotherapy for cutaneous squamous cell carcinoma.
  • Radiation therapy must have been completed 2-6 weeks before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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

19-415

Phase

III

Investigator