Avelumab is a human anti–PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in early-phase studies of patients with advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC), including a subgroup who received avelumab as first-line (1L) maintenance therapy. Here, we describe the design of JAVELIN Gastric 100 (NCT02625610), a randomized, open-label, Phase III trial. Approximately 466 patients with locally advanced/metastatic HER2− GC/GEJC adenocarcinoma, who have achieved at least stable disease following 12 weeks of treatment with 1L oxaliplatin/fluoropyrimidine chemotherapy, will be randomized 1:1 to receive either avelumab maintenance therapy or continuation of 1L chemotherapy. The primary endpoints are overall survival and progression-free survival, and secondary endpoints include best overall response, quality of life measures, safety, and tumor biomarkers.
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