Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05859477
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-05-01
Brief Title:
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
Sponsor:
Kidney Cancer Research Bureau
Organization:
Kidney Cancer Research Bureau
Study Overview
Official Title:
Nivolumab and CAPOX in Patients With FGFR2PD-L1-positive Metastatic Gastric Adenocarcinoma a Single-arm Phase 2 Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIVOFGFR2
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-positivePD-L1-positiveHER2-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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None