Nivo, a fully human IgG4 programmed death 1 (PD-1) immune checkpoint inhibitor antibody, has demonstrated survival benefits across various tumor types. In ATTRACTION-02 (ONO-4538-12), a double-blind, placebo-controlled Phase 3 study in patients (pts) with unresectable advanced or recurrent G/EGJ cancer refractory to or intolerant of standard therapy, Nivo alone (3 mg/kg Q2W) achieved significant survival benefits (overall survival [OS] and progression free survival) vs. placebo with a manageable safety profile (Yoon-Koo Kang, et al. 2017 ASCO GI Cancers Symposium). In pStage II/III G/EGJ cancer, postoperative adjuvant chemotherapy with tegafur-gimeracil-oteracil potassium (S-1) or oxaliplatin/capecitabine (CapeOX) is indicated standard of care in Asian countries. However, the efficacy of these treatments is still unsatisfactory in pts with pStage III G/EGJ cancer, and thus a new treatment strategy is required. This multinational trial will evaluate the efficacy and safety of Nivo in combination with standard adjuvant chemotherapy in pts with pStage III G/EGJ cancer (ClinicalTrials.gov Identifier: NCT03006705).
In this study, approximately 700 pts between 20 to 80 years of age with pStage III G/EGJ cancer after D2 or more extended lymph node dissection will be randomized to receive adjuvant chemotherapy (S-1 or CapeOX by investigator’s choice) + either Nivo or placebo. Treatment with Nivo, placebo, and S-1 therapy will be continued for up to 1 year, and CapeOX therapy will be administered for up to 6 months. Pts will be followed up for 5 years at maximum until consent withdrawal or the start of post-study treatment due to disease relapse. Primary endpoint is relapse free survival (RFS) by central assessment. Secondary endpoints are RFS by site investigator assessments, 3- and 5-year RFS rates by central and site investigator assessments, OS and 3- and 5-year OS rates. Japan, Korea, Taiwan and China will participate into the trial. This study has already started patient enrollment.
Clinical trial identification
Legal entity responsible for the study
Ono Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd, Bristol-Myers Squibb
M. Terashima: Taiho, Chugai, Lilly Japan, Yakult, Daiichi-Sankyo. H.C. Chung: Lilly, GSK, MSD, Merck-Serono, BMS/Ono, Taiho, Celltrion, Quintiles, BMS. N. Boku: Ono, Taiho, Chugai, Eli-Lily. Y-K. Kang: Ono, Bristol-Myers Squibb, Lilly/ImClone, Taiho Pharmaceutical, Roche/Genentech, Novartis, Bayer. L-T. Chen: Ono Pharmaceutical Co., Ltd, Eli Lilly, MSD, PharmaEngine, Merrimack, TTY, Syncore, Five Prime, Novartis, GSK, Merck Serono, Polaris, anti-alpha enolase (ENO-1) monoclonal antibody/HuniLife. M. Sasako: Taiho, Chugai, Lilly, Yakult, Olympus, Daiichisankyo. All other authors have declared no conflicts of interest.