nivolumab alone (n=240) vs. Standard of Care (SoC) (n=121)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight) every 2 weeks
ICC (methotrexate, docetaxel or cetuximab)
weekly intravenous administration of methotrexate (38.0%) at a dose of 40 to 60 mg/m2, docetaxel (43.0%)at 30 to 40 mg/m2, or cetuximab (10.7%)at 250 mg/m2 after a loading dose of 400 mg/m2
Dose modifications were not permitted for nivolumab but were specified for methotrexate, docetaxel, and cetuximab on the basis of the type and grade of the toxic effect.
mHNSCC - L2 - all population
an age of at least 18 years; an Eastern Cooperative Oncology Group performance-status score of 0 or 1
open-label
66 sites in 15 countries in North America, Asia, Europe, and South America
P3 / two-sided test procedure with one interim analysis. Hierarchical testing procedure for secondary endpoints PFS and ORR
Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy