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Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design

Authors
 Markus Moehler  ;  Min-Hee Ryu  ;  Mikhail Dvorkin  ;  Keun-Wook Lee  ;  Hasan Ş Coşkun  ;  Rachel Wong  ;  Hyun C Chung  ;  Artem Poltoratsky  ;  Akihito Tsuji  ;  Chia Jui Yen  ;  Alina S Muntean  ;  Samuel Le Sourd  ;  Gina M Vaccaro  ;  Lindsay Overton  ;  Narikazu Boku  ;  Zev A Wainberg  ;  Manish Patel  ;  Maitreyi Sharma  ;  Huiling Xiong  ;  Ilaria Conti  ;  Julien Taieb  ;  Yung-Jue Bang 
Citation
 FUTURE ONCOLOGY, Vol.15(6) : 567-577, 2019 
Journal Title
 FUTURE ONCOLOGY 
ISSN
 1479-6694 
Issue Date
2019
Keywords
PD-L1 ;  avelumab ;  gastric cancer
Abstract
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 Gastric100 (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.
Files in This Item:
T201902173.pdf Download
DOI
10.2217/fon-2018-0668
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/170362
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