Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
