CheckMate 451 (N ; all population), 2019 NCT02538666
nivolumab alone (n=280) vs. placebo (n=275)
randomized controlled trial
nivolumab
nivolumab 240 mg Q2W IV
placebo
3 arms: nivolumab, or nivolumab in combination with ipilimumab, or placebo as maintenance therapy Crossover was not permitted.
Extensive stage SCLC (Es-SCLC) - maintenance (M)
double-blind
168 sites in 32 countries
P3/ two sided and no interim analysis. Overall hierarchical testing procedure will be used to assess thesecondary endpoint (OS/N ; PFS (NI and N))
OS was not significantly prolonged in both arms (nivo plus ipi and nivo versus placebo)