In a randomized phase III Indian study, the addition of low dose nivolumab to chemotherapy improved overall survival in patients with recurrent/advanced head and neck squamous cell carcinoma.

In this randomized study published in the JCO, 151 patients were randomized to first line metronomic chemotherapy (oral methotrexate 9 mg/m2 once a week, celecoxib 200 mg twice daily, and erlotinib 150 mg once daily) versus the same metronomic regimen plus nivolumab 20 mg flat dose once every 3 weeks. The primary end point was 1-year OS.

Adding nivolumab improved the 1-year OS rate from 16.3% to 43.4% (p=0036). The median OS was 10.1 months with nivolumab versus 6.7 months in the chemotherapy-only arm. There was no significant differences in the rate of grade 3/4 adverse events between both arms.