Journal
FUTURE ONCOLOGY
Volume 15, Issue 6, Pages 567-577Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2018-0668
Keywords
avelumab; gastric cancer; PD-L1
Categories
Funding
- Merck KGaA
- Novartis
- AstraZeneca
- Merck Co
- Ono Pharmaceutical
- Roche
- Taiho Pharmaceutical
- Bristol-Myers Squibb
- Eli Lilly
- GlaxoSmithKline
- Celgene
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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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