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Treatment for Squamous Cell Skin Cancer

Study name: Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

Description: Researchers at the WL Nugent Cancer Center are conducting a Phase II clinical trial for treating advanced skin squamous cell cancer using the immunotherapy medications: avelumab and cetuximab. Immunotherapy medications use your body’s immune system to fight cancer.

The goal of this study is to determine whether the combination of the study drugs (avelumab and cetuximab) results in better patient outcomes than avelumab alone.

  • Group 1:  Receive immunotherapy medication avelumab alone for up to 24 cycles.  If tumor continues to grow, the patient may receive a combination of avelumab and cetuximab for up to 12 more cycles (if eligible based on the individual’s health conditions).
  • Group 2:  First receive a combination of avelumab and cetuximab for 12 cycles, then receive avelumab alone for cycles 13-24.

Who can participate?

This study is open to men and women age 18 and over who:

  • Have been diagnosed with advanced cutaneous squamous cell carcinoma
  • Do not have active second malignancy

What to expect

  • You will meet with your doctor to discuss what is involved in the study and the possible benefits and risks. If you and your doctor agree this clinical trial is right for you, you will be asked to sign a consent form.

  • This is a randomized study, where you will be assigned by chance to one of the treatment groups listed above.

  • You will periodically complete questionnaires about your condition, side-effects from treatment, etc.

  • Blood samples may be collected before, during, and after treatment for study analysis.


Please talk with your doctor about whether this clinical trial is right for you.