NRG-HN014 (Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called cemiplimab (the study drug) is a safe and effective option for people who have untreated cutaneous squamous cell carcinoma (CSCC). We want to know if the study drug can help shrink this cancer and prevent it from returning after it is treated with surgery.
Cutaneous Squamous Cell Carcinoma (CSCC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with CSCC
- Are a candidate for surgical resection
- Have not received previous treatment for their cancer
For more information about who can join this study, contact the study team at nick.jeffries@duke.edu.
What is Involved?
Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos:
- Group 1: If you are in this group, you will get the usual surgery used to treat this type of cancer. After surgery, you may get the usual type of radiation, depending on the results from the testing of tumor tissue removed during surgery.
- Group 2: If you are in this group, you will get the study drug before you get the usual surgery used to treat this type of cancer. The extent of your surgery may be less if the cancer shrinks after treatment with the study drug. After surgery, you may also get the usual type of radiation, depending on the results from the testing of tumor tissue removed during surgery. You might also get more doses of the study drug depending on those same test results.
If you are in Group 2 and testing shows that there is no remaining tumor tissue, then you will not receive radiation or any more doses of the study drug.
You will get the study drug through a vein in your arm. Before you have surgery, you will get the study drug once every 3 weeks for 12 weeks, for a total of up to 4 doses. You may have surgery sooner if you are unable to receive all 4 doses of the study drug because of side effects or a change in your cancer. After you have surgery, or radiation if given, and if you did not have to stop the study drug early before surgery and the tumor tissue results show surviving cancer, you will get the study drug once every 6 weeks for up to 24 weeks, for a total of up to 4 doses.
Study Details
