NCT05859477

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Kidney Cancer Research Bureau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Gastric Cancer
• PD-L1 Gene Amplification
• FGFR2 Amplification

Interventions

Type	Name	Description
DRUG	Nivolumab	360 mg, i.v., every 3 weeks
DRUG	Capecitabine	capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
DRUG	Oxaliplatin	130 mg/m², i.v., day 1, every 3 weeks

Timeline

• Start date: 2022-06-05
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-05-16
• Last updated: 2024-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study