A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)

Exclusion Criteria

• •Disease suitable for local therapy administered with curative intent
• •Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
• •Radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or not fully recovered from adverse events due to a previously administered treatment
• •Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks of the first dose of study medication
• •Life expectancy of \<3 months and/or has rapidly progressing disease
• •Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication (physiologic doses of corticosteroids may be approved after consultation with the Sponsor)
• •Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers
• •Has had an allogeneic tissue/solid organ transplant
• •Active central nervous system metastases and/or carcinomatous meningitis
• •Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment
• •History of (non-infectious) pneumonitis that required steroids or current pneumonitis
• •Active infection requiring systemic therapy
• •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study medication
• •Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or previously participated in Merck MK-3475 clinical trial
• •Known history of human immunodeficiency virus (HIV)
• •Known active Hepatitis B or C
• •Received a live vaccine within 30 days of planned start of study medication