ATTRACTION-2, 2017 trial summary

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

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NCT02267343    Lancet 2017;:  



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 sizes330 / 163
Inclusion criteriaaged ¡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



EndpointX1N1X0N0TE95% CI ORR - 330 - 163 no data OS - 330 - 163 0,63[0,51; 0,78] PFS - 330 - 163 no data0,22,01,0

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



Registering number NCT02267343 (see trial on clinicaltrials.gov)
Code Name ONO-4538-12