Study Comparing mFOLFIRINOX and mFOLFOX, With or Without Nivolumab, for Advanced HER2 Negative Esophageal, Gastroesophageal, and Gastric Cancer

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05677490

Provider View

This clinical trial is testing two different chemotherapy treatments, mFOLFIRINOX and mFOLFOX, to see which is more effective for patients with advanced esophageal, gastroesophageal, and gastric cancer that cannot be removed by surgery. Some patients will also receive an additional immunotherapy drug, nivolumab, to see if it helps improve treatment outcomes.

Patient Parameters

Program Overview

This study is comparing two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, for patients with advanced esophageal, gastroesophageal junction, and gastric cancer that cannot be surgically removed. The usual treatment is FOLFOX chemotherapy, which uses drugs to stop cancer cells from growing and spreading. This trial is testing if adding another drug, irinotecan, to the FOLFOX regimen (making it mFOLFIRINOX) can shrink the cancer and help patients live longer. Some patients will also receive an immunotherapy drug, nivolumab, which may help the immune system fight the cancer.

Description

The main goal of this study is to find out if patients live longer when treated with mFOLFIRINOX, with or without nivolumab, compared to those treated with mFOLFOX, with or without nivolumab, as the first treatment for advanced gastroesophageal cancer.

Other goals include comparing how long patients live without the cancer getting worse, how well the cancer responds to treatment, and how long the response lasts. The study will also look at the safety and side effects of the treatments, and how patients tolerate them.

Researchers will also explore certain biological markers to understand their impact on treatment outcomes.

Participants will be randomly assigned to one of two groups.

  • Group 1: Patients will receive mFOLFIRINOX (fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan) and may also receive nivolumab. They will have MRI and CT scans during the trial and may have blood samples taken.
  • Group 2: Patients will receive mFOLFOX (fluorouracil, leucovorin calcium, and oxaliplatin) and may also receive nivolumab. They will also have MRI and CT scans during the trial and may have blood samples taken.

Eligibility Criteria

Inclusion Criteria

  • Have HER2 negative esophageal, gastroesophageal junction, or stomach cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have measurable or evaluable disease based on specific medical criteria.
  • Have not received prior treatment for advanced cancer.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/mm^3.
    • Platelet count of at least 100,000/mm^3.
    • Creatinine level within normal limits or creatinine clearance of at least 30 mL/min.
    • Bilirubin level within normal limits.
    • Liver enzymes within specified limits.
  • Patients with HIV are eligible if they are on effective treatment and have an undetectable viral load.
  • Patients with a history of heart disease must have a clinical assessment showing they are in good condition.
  • Patients receiving nivolumab must not have any contraindications to immune checkpoint inhibitors, such as active autoimmune disease or recent use of high-dose steroids.
  • Must be able to complete patient-reported outcome measures in English, Spanish, Korean, Chinese, or Russian.

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Have known genetic conditions affecting drug metabolism.
  • Have significant nerve damage or other neurological issues.
  • Have uncontrolled infections or diabetes.
  • Have untreated or symptomatic brain metastases. Treated brain metastases are allowed if stable.
  • Have had an organ transplant.

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