Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Main objective of the trial:

The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

Inclusion Criteria:

• Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
• Has or be willing to provide tumor tissue for testing
• Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
• Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Has adequate hematological function per protocol
• Has adequate renal function per protocol
• Has adequate hepatic function per protocol
• Agrees to use effective contraception while on the study and for 6-months after the end of the study
• Provides written informed consent(s)

Exclusion Criteria:

• Has left ventricular ejection fraction (LVEF) <50%
• Had prior epidermal growth factor receptor (EGFR) targeted regimen
• Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
• Had prior chemotherapy for recurrent/metastatic disease
• Had anti-cancer therapy between biopsy and submission of sample
• Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
• Has known history of brain metastases or active brain metastases
• Has uncontrolled hypertension
• Has clinically significant electrocardiograph (ECG) findings
• Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
• Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
• Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment