Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Inclusion Criteria:

• Body weight > 30 kg
• Histologically or cytologically confirmed recurrent or metastatic HNSCC
• Not considered a candidate for other curative therapy (i.e. surgery/RT)
• Documented progression of disease after receiving platinum based regimen
• ECOG performance status 0-2

Exclusion Criteria:

• Nasopharyngeal and salivary gland tumors
• Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.