Model-based evaluation of the efficacy and safety of nivolumab once every 4 weeks across multiple tumor types.

•The benefit–risk profile of nivolumab 480 mg Q4W versus 3 mg/kg Q2W was evaluated by population PK and exposure–response analyses.•The benefit–risk profile for nivolumab 480 mg Q4W was predicted to be similar to 3 mg/kg Q2W across tumor types.•Predicted overall survival, objective response rate, and safety of nivolumab 480 mg Q4W were similar to 3 mg/kg Q2W.•The extended dosing frequency of nivolumab is a convenient and flexible treatment option for patients and caretakers.