Kidney Cancer Clinical Trial
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
Summary
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
Pregnancy
Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
Surgery within 7 days before the first dose of the study drug
Signs of bleeding or hemorrhagic diathesis
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