January 14 2025
NRG Oncology recently activated the NRG-HN014 clinical trial as a part of the group’s head and neck cancer portfolio. NRG-HN014 is a phase III study testing if the addition of the immunotherapy drug cemiplimab before response-adapted oncologic surgery and if indicated, adjuvant radiation therapy can improve survival outcomes for patients when compared to standard of care surgery and adjuvant radiotherapy for patients with resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).
“Rates of cutaneous cell carcinoma continue to rise drastically and there is an unmet need for improved oncologic and functional outcomes for this population,” stated Neil D. Gross, MD, FACS of the MD Anderson Cancer Center and the Principal Investigator of the NRG-HN014 clinical study. Most CSCC develop in the head and neck region. “Due to the proximity of this cancer to critical tissues in the human body, many patients experience severe destructive effects from treatment, especially patients with locoregionally advanced disease. We need to continue to define new, better treatments for these patients.”
Prior research has indicated that CSCC is uniquely responsive to immunotherapy and has been previously approved in the setting of advanced CSCC that is not amendable to surgery. NRG-HN014 was designed in an effort to fill this unmet need and potentially shift the standard of care in advanced, resectable CSCC.
Eligible patients enrolled onto NRG-HN014 will be stratified by immunosuppression and advanced nodal disease then randomly assigned to one of two potential treatment arms. Patients on treatment arm 1 will receive standard of care surgery followed by adjuvant radiotherapy. Patients on treatment arm 2 will receive neoadjuvant cemiplimab followed by response-adaptive oncologic surgery. Based on pathologic results, patients on treatment arm 2 may receive adjuvant radiation and/or adjuvant cemiplimab.
The primary objective of this study is to determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival when compared to the standard of care. Secondary objectives include comparing disease-free survival, overall survival, and adverse events between treatment arms. Additionally, the trial will be assessing pathologic complete response in treatment arm 2. Patient-reported outcomes and multiple exploratory outcomes are also being assessed on this trial.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website
The patient study webpage for this trial can be found at www.nrgoncology.org/HN014