Spots Global Cancer Trial Database for Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

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Trial Identification

Brief Title: Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

Official Title: Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study

Study ID: NCT05859477

Conditions

Metastatic Gastric Cancer

PD-L1 Gene Amplification

FGFR2 Amplification

Interventions

Nivolumab

Capecitabine

Oxaliplatin

Study Description

Brief Summary: The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.

Detailed Description: 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.