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

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent obtained from the patient/legal representative
* Histologically confirmed recurrent or metastatic SCCHN
* Tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
* Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
* Confirmed PD-L1-positive SCCHN by Ventana SP263 assay
* WHO/ECOG performance status of 0 or 1
* At least 1 measurable lesion at baseline
* No prior exposure to immune-mediated therapy
* Adequate organ and marrow function
* Evidence of post-menopausal status or negative urinary or serum pregnancy test.

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