Full Title
Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (NRG-HN014) (CIRB)Purpose
The usual care for people with squamous cell skin cancer is surgery, with or without radiation therapy. Sometimes the cancer comes back (recurs). For this reason, researchers are studying other treatments for squamous cell skin cancer.
Researchers want to see if adding cemiplimab immunotherapy to the usual treatment is better than the usual treatment alone. The people in this study have squamous cell skin cancer that is locally advanced. This means it is relatively large or deep or has spread to nearby lymph nodes. Cemiplimab works by boosting the immune system to find and kill skin cancer cells.
If you join this study, you will be randomly assigned to have either:
- Cemiplimab with the usual treatment for squamous cell skin cancer
- The usual treatment without cemiplimab
Cemiplimab will be given before surgery. Some people will also get it after surgery and radiation therapy. Cemiplimab is given intravenously (by vein).
If the squamous cell skin cancer recurs, patients and their doctors will decide on the best treatment at that time. This treatment may include cemiplimab.
Who Can Join
To join this study, there are a few conditions. You must:
- Have stage 3 or 4 squamous cell skin cancer that can be removed with surgery.
- Not have had prior anti-cancer medication for squamous cell skin cancer.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Christopher Barker’s office at 212-639-8168.