This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).
Patients 18 years or older.
Patients with surgically resectable squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx. Resectability will be determined by the treating surgeon. Patients must have locoregionally advanced disease defined by clinical T3-4 staging and/or clinical node positive staging.
A CPS score of at least 1 on initial biopsy.
Zubrod, or Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
HPV-positive squamous cell carcinoma of the oropharynx.
Tumor inaccessible for clinic-based biopsy as determined by the treating surgeon.
Solid organ transplant requiring chronic immunosuppression.
Autoimmune disease requiring use of steroids or chronic immunosuppression.