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.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with CSCC
- Are a candidate for surgical resection
- Have not received previous treatment for their cancer
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- 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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
NRG-HN014, 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
Principal Investigator
Jameel
Muzaffar
Protocol Number
PRO00118416
NCT ID
NCT06568172
Phase
III
Enrollment Status
Pending Open to Enrollment