NRG-HN014 (Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma)

NRG-HN014 (Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma)

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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
For more information about who can join this study, contact the study team at nick.jeffries@duke.edu.

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.
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.

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