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

Markus Moehler, Min Hee Ryu, Mikhail Dvorkin, Keun Wook Lee, Hasan 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 ContiJulien Taieb, Yung Jue Bang

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

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 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.

Original languageEnglish (US)
Pages (from-to)567-577
Number of pages11
JournalFuture Oncology
Volume15
Issue number6
DOIs
StatePublished - Feb 2019

Keywords

  • PD-L1
  • avelumab
  • gastric cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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