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Trial Title:
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
NCT ID:
NCT05859477
Condition:
Metastatic Gastric Cancer
PD-L1 Gene Amplification
FGFR2 Amplification
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Nivolumab
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Nivolumab in combination with chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
360 mg, i.v., every 3 weeks
Arm group label:
Nivolumab in combination with chemotherapy
Other name:
Opdivo
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
Arm group label:
Nivolumab in combination with chemotherapy
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg/m², i.v., day 1, every 3 weeks
Arm group label:
Nivolumab in combination with chemotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bureau for Cancer Research
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Magnolia Rouge
Phone:
917-981-6485
Email:
bucare@bucare.org
Start date:
June 5, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Kidney Cancer Research Bureau
Agency class:
Other
Source:
Kidney Cancer Research Bureau
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05859477
