A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma
of the head and neck (R/M SCCHN)

- Progressive disease on or after first-line platinum-based chemotherapy regimen for
R/M SCCHN (maximum of 6 cycles)

- No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed

- Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced
disease is allowed if completed/terminated >/= 6 months before the platinum-based
regimen for R/M SCCHN

- Consent to provide archival tumor tissue for biomarker testing

- Measurable disease per RECIST v1.1

- ECOG performance status of 0, 1 or 2

- Adequate hematologic, renal and liver function

Exclusion Criteria:

- Nasopharyngeal cancer

- Prior treatment with an investigational or approved agent for the purpose of
inhibiting HER family members

- This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and
lapatinib

- Prior treatment with an EGFR inhibitor is allowed if it was administered as part of
definitive therapy for locally advanced disease and completed >/=1 year before study
enrollment

- Leptomeningeal disease as the only manifestation of the current malignancy

- Active infection requiring iv antibiotics

- Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory
drugs

- Current severe, uncontrolled systemic disease (e.g. clinically significant
cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers;
bone fractures)

- History of heart failure or serious cardiac arrhythmia

- History of myocardial infarction within 6 months of Cycle 1, Day 1

- Clinically significant liver disease, including active viral, alcoholic or other
hepatitis, cirrhosis, or current alcohol abuse

- HIV infection

- Primary central nervous system (CNS) malignancy or untreated/active CNS metastases
(progressing or requiring anticonvulsants or corticosteroids for symptomatic control)

- Pregnant or lactating women

- Malignancies other than SCCHN within 5 years prior to randomization, with the
exception of adequately treated basal or squamous cell skin cancer and carcinoma in
situ of the cervix