Correlative studies from the CIM phase II and phase III trials demonstrate that serum EGF levels (both pretreatment and during vaccination) can identify the patients that will most benefit from vaccination. The evidence from the clinical studies with CIMAvax supports the use of this vaccine in advanced NSCLC. Nivolumab is currently recommended as the second line treatment for advanced NSCLC (including squamous cell and adenocarcinomas). The MTD and optimal monthly dosing interval required to maintain the antibody titer for the CIMAvax will be evaluated when the vaccine is administered with Nivolumab in the Phase I study. The effect on PFS and OS will be evaluated in the Phase II study.