Study on Bemarituzumab with Chemotherapy and Nivolumab Compared to Chemotherapy and Nivolumab for Untreated Advanced Gastric and Gastroesophageal Junction Cancer with FGFR2b Overexpression

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05111626

Provider View

This clinical trial is testing a new treatment combination of bemarituzumab with chemotherapy and nivolumab against the standard treatment of chemotherapy and nivolumab in patients with advanced gastric and gastroesophageal junction cancer that overexpresses FGFR2b.

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 focuses on checking the safety and how well patients can tolerate the combination of bemarituzumab with chemotherapy drugs (5-fluorouracil, leucovorin, and oxaliplatin) and nivolumab. Part 2 aims to compare how effective this new combination is against the standard treatment of chemotherapy and nivolumab, by looking at how long patients live overall.

Eligibility Criteria

Exclusion Criteria

  • Have previously received treatment targeting the FGF-FGFR pathway.
  • Have a known positive status for HER2.
  • Have untreated or symptomatic cancer spread to the brain or spinal cord.
  • Have nerve damage causing numbness or tingling at grade 2 or higher.
  • Have significant heart disease.
  • Have had another cancer within the last 2 years, except for certain treated cases.
  • Have chronic or systemic eye disorders.
  • Have had major surgery or participated in another study within 28 days before starting this trial.
  • Have received palliative radiotherapy within 14 days before starting this trial.
  • Have corneal abnormalities that increase the risk of corneal ulcers.
  • Have an active autoimmune disease needing treatment in the past 2 years or any condition requiring immunosuppressive therapy during the study.

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