2021 Volume 47 Issue 1 Pages 10-14
In Japan, as of September 2020, two immune checkpoint inhibitors, nivolumab and pembrolizumab, have been approved for squamous cell carcinoma of the head and neck, and clinical evidence is being generated. Here, we review the two clinical trials (CheckMate 141 trial and KEYNOTE-048 trial) that were registration studies for marketing authorization, focusing on the differences between the two studies in the eligible patients, study design, concomitant drugs, and control drugs. In particular, both trials have different eligibility criteria for prior platinum treatment, which will also be explained.