Study on Nivolumab and Chemotherapy for FGFR2-positive Metastatic Stomach Cancer

Sponsor: Kidney Cancer Research Bureau

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05859477

Provider View

This phase 2 clinical trial is testing the effectiveness of combining nivolumab with chemotherapy in patients with FGFR2-positive, PD-L1-positive, and HER2-negative metastatic stomach cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug nivolumab, when used with chemotherapy (CAPOX), can help treat patients with a specific type of advanced stomach cancer that has spread to other parts of the body. This cancer is characterized by certain markers: FGFR2-positive, PD-L1-positive, and HER2-negative. The study aims to find out if this combination treatment can improve outcomes for these patients.

Description

Nivolumab, in combination with chemotherapy, has been approved by the FDA for treating advanced stomach cancer. This treatment is particularly beneficial for patients whose cancer cells express a marker called PD-L1. Another marker, FGFR2, is associated with a poorer prognosis, and this study is exploring whether nivolumab is effective for patients whose cancer cells express both PD-L1 and FGFR2. The study will evaluate how well this combination treatment works in shrinking tumors and improving survival rates in this specific group of patients.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic stomach cancer that cannot be removed by surgery and has not been treated before.
  • Have tumors that can be measured using standard criteria.
  • Have a PD-L1 score of 5 or more, as determined by a specific lab test.
  • Have cancer cells that show moderate to strong FGFR2 expression in more than 1% of the cells.
  • Be able to test for FGFR2 amplification.
  • Have HER2-negative cancer.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Be 18 years or older.
  • Have organs that are functioning well.
  • Have no psychological, family, social, or geographical issues that could interfere with participating in the study.
  • Agree to sign an informed consent form.

Exclusion Criteria

  • Participating in another clinical trial or receiving any experimental treatment within 28 days before joining this study.
  • Have cancer that has spread to the brain or the membranes covering the brain and spinal cord.
  • Have any condition or treatment that could affect the study results.
  • Have had another type of cancer in the past 5 years, except for certain skin cancers or cervical cancer that have been treated successfully.
  • Be pregnant.
  • Have known HIV or active hepatitis B or C infections.
  • Have had surgery within 7 days before starting the study treatment.
  • Have signs of bleeding disorders.

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