NRG14-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

To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).


Why this Research Matters

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.


Who can Participate

Adult

Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.https://clinicaltrials.gov/study/NCT06568172


Study ID

Protocol Number: 25-1924

More information available at ClinicalTrials.gov: NCT06568172


Meet the Team

Image of Principal Investigator

Carissa Thomas, MD, PhD, FACS

Principal Investigator