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

Metastatic Gastric Cancer Clinical Trial

— NIVOFGFR2  

Official title:

Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859477
• Other study ID #: NIVOFGFR2
• Status: Recruiting
• Phase: Phase 2
• Start date: June 5, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Kidney Cancer Research Bureau
• Contact: Ilya Tsimafeyeu
• Phone: +19178914943
• Email: director[@]bucare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• FGFR2 Amplification
• Metastatic Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Nivolumab
360 mg, i.v., every 3 weeks
• Capecitabine
capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
• Oxaliplatin
130 mg/m², i.v., day 1, every 3 weeks

Locations

Country	Name	City	State
United States	Bureau for Cancer Research	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year progression-free survival (PFS)	Proportion of patients who will be progression-free at 1 year	12 months
Secondary	Median PFS	From first day of treatment to the first observation of disease progression or death due to any cause	18 months
Secondary	Median overall survival (OS)	From first day of treatment to time of death due to any cause.	24 months
Secondary	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	18 months
Secondary	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.	Up to 30 days post treatment