A randomised clinical trial investigating the effect of nivolumab versus placebo in patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens
Studied treatment | nivolumab at 3 mg/kg every 2 weeks |
Control treatment | placebo |
Patients | patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens |
Group sizes | 330 / 163 |
Inclusion criteria | aged ¡Ý20 years with unresectable advanced or recurrent gastric or gastrooesophageal junction cancer refractory to, or intolerant of, standard therapy [including two or more previous chemotherapy regimens], with an Eastern Cooperative Oncology Group [ECOG] performance status of 0¨C1, and naive to anti-PD-1 therapy or other therapeutic antibodies and pharmacotherapies for the regulation of T cells) |
Blindness | double blind | Inclusion period | |
Follow-up duration | Centers | 49 | |
Lost to FU | geographical localisation | Japan, South Korea, and Taiwan | |
Primary endpoint | OS | Design | Parallel groups |
Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017;: [PMID: 28993052] link to pdf add to Mendeley
ClinicalTrial.gov record NCT02267343
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