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

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Moehler M., Ryu M., Dvorkin M., Lee K., COŞKUN H. Ş., Wong R., ...More

FUTURE ONCOLOGY, vol.15, no.6, pp.567-577, 2019 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 15 Issue: 6
  • Publication Date: 2019
  • Doi Number: 10.2217/fon-2018-0668
  • Journal Name: FUTURE ONCOLOGY
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.567-577
  • Keywords: avelumab, gastric cancer, PD-L1, SUPPORTIVE CARE, SOLID TUMOR, BEVACIZUMAB, 2ND-LINE, PATHWAYS, THERAPY
  • Akdeniz University Affiliated: Yes

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.