CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer

Inclusion Criteria

• Patients with histologically confirmed recurrent and/or metastatic SCCHN not eligible for local treatment.
• Patients with measurable disease according to RECIST 1.1.
• Patients aged at least 18 years at screening.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Minimum life expectancy of 3 months.
• Tissue samples available for specific and therapy-related biological assessments.
• If female and of childbearing potential, was non-lactating and had negative pregnancy test results at screening and prior to randomization.
• If female, was either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or willing to use highly effective contraceptives during study participation until 6 months after last administration of any study medication, particularly cisplatin or carboplatin, with a failure rate 1.5 fold above the upper limit of normal ranges, creatinine clearance 5-fold above the upper limit of normal ranges) and patients with hematology parameters outside the normal ranges (hemoglobin <9 g/dL, absolute neutrophil count <1500/mm3 and platelet count <105/mm3) at screening as well as patients with impaired auditory function or platinum-related neuropathy.
• Clinically active infections ≥Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics.
• Known active hepatitis B or C.
• Known human immunodeficiency virus (HIV) infection.
• Myocardial infarction within 6 months prior to screening.
• Symptomatic congestive heart failure (New York Heart Association Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke, or transient ischemic attack within 1 year prior to screening.
• History of keratitis requiring medical interventions within the last 5 years or interstitial lung disease.
• Patients with any other disorder that, in the opinion of the investigator, might have interfered with the conduct of the study.
• Patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
• Patients institutionalized by official means or court order.
• Receipt of any other IMP within the last 30 days before randomization or any previous CetuGEX™ administration.
• Prior allergic reaction to a monoclonal antibody, grade 3 infusion related reaction (IRR) or any grade 4 reaction to a monoclonal antibody.
• Known sensitivity to any component of the IMP and medication used in this study.
• Known dihydropyrimidine dehydrogenase deficiency (France only).