Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •1. Has disease that is suitable for local therapy administered with curative intent.
• •2. Has a life expectancy of less than 3 months and/ or has rapidly progressing disease in the opinion of the treating investigator.
• •3. Has received prior systemic anti-cancer therapy including radiation therapy, other non-systemic therapy or investigational agents within 4 weeks prior to the first dose of trial treatment.
• •4. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of treatment.
• •5. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (using prednisolone ≥ 10mg per day) or any other form of immunosuppressive therapy within 7 days prior to the first dos e of trial treatment.
• •6. Has a diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected esophageal cancer, curatively resected in situ cervical cancer, and curatively resected in situ cancer.
• •7. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •8. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• •9. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. Pneumonitis include active radiation pneumonitis.
• •10. Has an active infection requiring systemic therapy.
• •11. Has received prior therapy with an anti-PD-1, a nti-PD-L1, or anti-CTLA-4 agent.
• •12. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).