Trial in Development Feature: NRG-HN014

April 10 2024

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

NRG-HN014 is an upcoming registrational-intent, randomized phase III trial currently in development within NRG Oncology’s head and neck portfolio. The trial will be accruing patients with resectable stage III/IV cutaneous squamous cell carcinoma, stratifying them by immunosuppression and advanced nodal disease, then randomizing patients to either receive standard of care surgery with adjuvant radiotherapy or the experimental treatment arm. The experimental treatment arm consists of neoadjuvant cemiplimab, followed by response-adapted oncologic surgery, then indicated adjuvant therapy, including radiotherapy if indicated by pathologic features. The primary aim of this study is to determine if perioperative immunotherapy with response-adapted surgery can improve investigator-assessed event-free survival for this patient population compared to the standard of care treatment of up-front surgery.

“Typically, advanced, resectable cutaneous squamous cell carcinoma is managed with surgery and adjuvant radiation, however, these cancers typically involve the head and neck and are often close in proximity to important functional structures. This can lead to treatment-related functional impairment, disfiguration, and reduction in quality of life. There has been promising data to suggest that neoadjuvant immunotherapy could be beneficial in treating this patient population,” stated Neil Gross, MD, FACS at the University of Texas MD Anderson Cancer Center and the Principal Investigator of the NRG-HN014 trial.

More information will be circulated when this trial activates. 

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