Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to PD-1 receptor and blocks its interaction with PD-L1 and PD-L2. It is authorized in the EU since 19.06.2015 for monotherapy of advanced (unresectable or metastatic) melanoma and after prior chemotherapy for the treatment of advanced renal cell carcinoma and locally advanced or metastatic non-small cell lung cancer. Clinical activity was noted across a range of doses (0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg). The safety profile of nivolumab monotherapy is manageable and generally consistent across completed and ongoing clinical trials with no maximum tolerated dose (MTD) reached at any dose tested up to 10 mg/kg.