Study on Nivolumab with FOLFOX and Regorafenib for HER2-Negative Esophagogastric Cancer

Inclusion Criteria

• Have a confirmed diagnosis of metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.
• Cancer must be visible on scans within 28 days before starting the study treatment.
• 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 mild or no nerve damage (peripheral neuropathy grade ≤1).
• Provide a previous tumor sample for analysis, or be willing to have a biopsy if no sample is available.
• Have adequate organ function, including:
  • Neutrophil count of at least 1500/mcL.
  • Platelet count of at least 100,000/mcL.
  • Hemoglobin level of at least 9 g/dL.
  • Normal kidney and liver function as indicated by specific blood tests.

Exclusion Criteria

• Have HER2-positive cancer.
• Cannot swallow pills.
• Have had chemotherapy for metastatic cancer, unless it was more than 6 months ago for localized cancer.
• Are currently in another study or have been in one within the last 4 weeks.
• Have had major surgery within the last 4 weeks.
• Have had radiation therapy within the last 2 weeks.
• Have previously been treated with regorafenib or similar drugs.
• Have a weakened immune system or are taking medications that suppress the immune system.
• Have active tuberculosis or certain brain conditions.
• Have a history of lung inflammation or autoimmune diseases, except for certain stable conditions.
• Have HIV, active hepatitis B or C, or have received a live vaccine recently.
• Have significant heart disease or uncontrolled high blood pressure.
• Have bleeding disorders or psychiatric conditions that would interfere with the study.
• Are pregnant, breastfeeding, or planning to have children during the study.
• Are unwilling to provide informed consent or unable to follow the study requirements.