Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

Inclusion criteria

• . Patients with squamous cell carcinoma of the head and neck region, (including mucosal,cutaneous, or nodal) who are planned for surgical resection and in the opinion of the investigator are able to safely undergo neoadjuvant anti-PD-1 and radiation. In addition, the following are eligible (but will not contribute toward total accrual): non-surgical cases that are planned for palliative RT or that refuse or are unfit for definitive concurrent chemotherapy.
• . HPV status as determined by p16 immunostain
• . Cohort 3: HPV-positive patients only
• . Cohort 4: HPV-negative patients only
• . Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document. Patients with history of psychiatric illness must be judged by the investigator as able to understand the investigational nature and risks associated with the therapy.
• . Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by investigator for study requirements.
• . Laboratory values (most recent), must be within 6 weeks of week 0 on study:
• . Women of child-bearing potential (WOCBP) must agree to follow adequate contraceptive practices to avoid pregnancy for the duration of treatment with nivolumab plus 5 half-lives of nivolumab (75 days) plus 30 days (duration of ovulatory cycle) for a total of 105 days post-treatment completion.

Exclusion criteria