Checkmate-141, 2016 trial summary

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

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NCT02105636    N Engl J Med 2016;375:1856-1867  
2nd line platinum failure



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
Size361



Blindness open-label Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint overall survival Design Parallel groups



EndpointX1N1X0N0TE95% CI OS - 361 - 0 0,70[0,51; 0,96] PFS - 361 - 0 0,89[0,70; 1,13] ORR - 361 - 0 no data0,22,01,0

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



Registering number NCT02105636 (see trial on clinicaltrials.gov)
Code Name