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

NCT ID: NCT05859477

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2024-12-01

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-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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab in combination with chemotherapy

Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

360 mg, i.v., every 3 weeks

Capecitabine

Intervention Type: DRUG

capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle

Oxaliplatin

Intervention Type: DRUG

130 mg/m², i.v., day 1, every 3 weeks

Interventions

Nivolumab

360 mg, i.v., every 3 weeks

Intervention Type: DRUG

Capecitabine

capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle

Intervention Type: DRUG

Oxaliplatin

130 mg/m², i.v., day 1, every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Opdivo; Xeloda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kidney Cancer Research Bureau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya Tsimafeyeu

Role: STUDY_CHAIR

Bureau for Cancer Research

Locations

Bureau for Cancer Research

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ilya Tsimafeyeu

Role: CONTACT

director@bucare.org

+19178914943

Facility Contacts

Magnolia Rouge

Role: primary

bucare@bucare.org

917-981-6485

Other Identifiers

NIVOFGFR2

Identifier Type: -

Identifier Source: org_study_id