CheckMate 141

CheckMate 141, trial NCT02105636 sponsored by Bristol Myers Squibb and reported in 2016, was the first immunotherapy to extend survival in head and neck cancer, in patients whose disease had progressed on platinum within six months. It randomised 361 patients to nivolumab or investigator's choice of methotrexate, docetaxel or cetuximab, met its primary overall survival endpoint with a durable tail at two years, and preserved quality of life where chemotherapy worsened it, leading to FDA approval in November 2016. OnCo links it to head and neck squamous cell carcinoma, PD-1 as a target and nivolumab, and KEYNOTE-040 with pembrolizumab showed a concordant, borderline survival benefit. Whether the minority with durable benefit can be identified in advance remains the open question for second-line immunotherapy.