On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.~Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.~The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CapeOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.