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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
360 mg, i.v., every 3 weeks
capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
130 mg/m², i.v., day 1, every 3 weeks
Bureau for Cancer Research
New York, New York, United States
RECRUITING1-year progression-free survival (PFS)
Proportion of patients who will be progression-free at 1 year
Time frame: 12 months
Median PFS
From first day of treatment to the first observation of disease progression or death due to any cause
Time frame: 18 months
Median overall survival (OS)
From first day of treatment to time of death due to any cause.
Time frame: 24 months
Objective response rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 18 months
Toxicity Summary
toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.
Time frame: Up to 30 days post treatment
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