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CheckMate 451 (NI ; all population), 2019 NCT02538666

nivolumab plus ipilimumab (n=279) vs. placebo (n=275)

randomized controlled trial

Studied treatment

nivolumab plus ipilimumab
nivo 1 mg/kg þ ipi 3 mg/kg Q3W intravenously

Control treatment

placebo

3 arms: nivolumab, or nivolumab in combination with ipilimumab, or placebo as maintenance therapy Crossover was not permitted.

Patients

Extensive stage SCLC (Es-SCLC) - maintenance (M)

Method

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))

Remark

OS was not significantly prolonged in both arms (nivo plus ipi and nivo versus placebo)