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CheckMate 649: Study design1
A multicentre, randomised, open-label, phase 3 trial comparing nivolumab with fluoropyrimidine and platinum based combination chemotherapy for previously untreated, unresectable, advanced or metastatic gastric, GEJ, or esophageal adenocarcinomas.
- Patients who discontinued chemotherapy were permitted to receive OPDIVO monotherapy at 240 mg q2w, 360 mg q3w, or 480 mg q4w for up to 2 years after treatment initiation
- The efficacy analysis in patients with PD-L1 CPS ≥ 5 included 473 patients in the OPDIVO + FOLFOX or CapeOx arm and 482 patients in the FOLFOX or CapeOx arm
- Median follow-up at the 36-month analysis was 47.4 months in the OPDIVO + FOLFOX or CapeOx arm and 47.3 months in the FOLFOX or CapeOx arm2
References:
- Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021;398(10294):27-40.
- Janjigian YY, et al. First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. J Clin Oncol. 2024 Jun 10;42(17):2012-2020.
7356-NO-2500069 / Developed 11.11.2025