Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common
clinical situation and although this group of patients has very heterogeneous disease
characteristics, they share a dismal prognosis with a median survival time around 6-11 months
and a relatively poor quality of life.
Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty
cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC)
and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for
recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361
patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this
condition and whose disease had progressed within 6 months after platinum-based chemotherapy.
In this study, treatment with nivolumab resulted in significantly longer survival than
treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months
(p=0.01).
The main objective of the study is to provide additional insight into the frequency of
high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety
database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head
and neck patients.