NRG-HN015

Open to Accrual

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A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients with Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Principal Investigator

Nabil Saba, MD

Status

Open to Accrual


Disease Site

Head and Neck [HN] Other

Phase

II

Developmental Therapeutics

No

Primary Objective

To assess and compare investigator-assessed event-free survival (EFS) of patients treated with chemotherapy (carboplatin + paclitaxel) or chemo-immunotherapy (carboplatin + paclitaxel + cemiplimab [REGN2810]) prior to salvage surgery (SS) versus patients undergoing standard of care SS.

Patient Population

Patients must have pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx AND are deemed candidates for salvage surgery.

Target Accrual

180

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.