S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design
- Moehler, Markus; Ryu, Min-Hee; Dvorkin, Mikhail; Lee, Keun-Wook; Coskun, Hasan S.; Wong, Rachel; Chung, Hyun C.; Poltoratsky, Artem; Tsuji, Akihito; Yen, Chia Jui; Muntean, Alina S.; Le Sourd, Samuel; Vaccaro, Gina M.; Overton, Lindsay; Boku, Narikazu; Wainberg, Zev A.; Patel, Manish; Sharma, Maitreyi; Xiong, Huiling; Conti, Ilaria; Taieb, Julien; Bang, Yung-Jue
- Issue Date
- Future Oncology, Vol.15 No.6, pp.567-577
- Avelumab is a human anti-PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in early phase studies in advanced/metastatic gastric/gastroesophageal junction cancer, including as first-line maintenance therapy. Here, we describe the design of JAVELIN Gastric 100 (NCT02625610), an open-label, Phase III trial. A total of 499 patients with locally advanced/metastatic HER2- gastric/gastroesophageal junction cancer adenocarcinoma, who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy, have been randomized 1:1 to receive avelumab maintenance therapy or continue chemotherapy. The primary objective is to demonstrate superior overall survival in all randomized patients or in the PD-L1+population. Secondary objectives are to demonstrate superiority for progression-free survival and objective response rate, compare quality of life measures, and determine safety.
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