Phase II study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Exclusion Criteria

• - Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
• - Received more than 1 systematic palliative regimen for recurrent or metastatic disease
• - Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
• - Prior randomization or treatment in a previous MEDI4736 and/or tremelimumab clinical study regardless of treatment arm assignment or receipt of any investigational anticancer therapy within 28 days or 5 half-lives
• - Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment
• - Major surgical procedure within 28 days prior to the first dose of Investigational Product
• - Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion
• - Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736
• - History of allogeneic organ transplantation
• - Active or prior documented autoimmune or inflammatory disorders;
• - Uncontrolled intercurrent illness
• - Another primary malignancy
• - Patients with history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
• - History of active primary immunodeficiency
• - Known history of previous tuberculosis
• - Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• - Receipt of live, attenuated vaccine within 30 days prior to the first dose of MEDI4736
• - Pregnant or breast-feeding female patients
• - Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
• - Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results