Safety and Efficacy of MEDI0457 and Durvalumab in Patients With HPV Associated Recurrent/Metastatic Head and Neck Cancer

Inclusion Criteria:

1. Male and female subjects 18 years and older

2. Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a
p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid
testing.

3. Recurrent or metastatic disease that has been treated with at least one
platinum-containing regimen and lacking a curative treatment option.

4. Patients who are platinum ineligible may be enrolled if they have received and failed
an approved treatment and lack a treatment option with curative potential.

Exclusion criteria:

1. Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy
for cancer treatment Active or prior documented autoimmune disease with some
exceptions.

2. Current or prior use of immunosuppressive medication within 14 days prior to first
study dose, with the exception of intranasal and inhaled corticosteroids or systemic
corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids
as premedication for hypersensitivity reactions due to radiographic contrast agents
are allowed.

3. No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and
natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and
anti-CTLA4, etc).