Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
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.
• Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
• Measurable lesions according to the RECIST 1.1 criteria
• PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
• Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
• Possibility to assess the amplification of FGFR2
• HER2-negative status
• ECOG PS 0-2
• Age \>= 18 years old
• Adequate function of organs
• Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
• Signed Informed Consent