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 (C-PRE)

Principal Investigator

Neil Gross, MD

Status

Disease Site

Head and Neck [HN] Other

Phase

III

Developmental Therapeutics

No

Primary Objective

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

Patient Population

Pathologically (histologically or cytologically) proven diagnosis of invasive CSCC or regional lymph node or in-transit metastasis of CSCC, clinical AJCC 8^th Edition (head and neck sites) or UICC (non-head and neck sites) stage III or IV. Tumor must be resectable with curative intent, with at least 1 lesion measurable by RECIST 1.1.

Target Accrual

420