A randomised clinical trial investigating the effect of nivolumab versus standard treatment in patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy
Studied treatment | nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks |
Control treatment | standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). |
Patients | patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy |
Size | 361 |
Blindness | open-label | Inclusion period | |
Follow-up duration | Centers | ||
Lost to FU | geographical localisation | ||
Primary endpoint | overall survival | Design | Parallel groups |
Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med 2016;375:1856-1867 [PMID: 27718784] link to pdf add to Mendeley
ClinicalTrial.gov record NCT02105636
Appears in following systematic reviews: