A022102 - Randomized Phase 3 Trial Of Mfolfirinox +/- Nivolumab Vs. Folfox +/- Nivolumab For First-Line Treatment Of Metastatic Her2-Negative Gastroesophageal Adenocarcinoma

This study is being done to answer the following question: Can we extend your life after the diagnosis of your cancer in the stomach, esophagus, or gastroesophageal junction by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for treatment of your cancer in the stomach, esophagus, or gastroesophageal junction. The usual approach is defined as care most people get for cancer in the stomach, esophagus, or gastroesophageal junction.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

• HER2 negative gastroesophageal adenocarcinoma with known PD-L1 CPS.
• Measurable disease or non-measurable but evaluable disease as defined by RECIST 1.1.
• Age ≥ 18 years.
• ECOG performance status 0 or 1.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

• Prior treatment for metastatic disease.
• Allogeneic tissue/organ transplant.
• Known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism.
• Certain peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity.
• Uncontrolled infection.
• Uncontrolled diabetes mellitus or cardiac disease.
• Active autoimmune disease requiring systemic treatment with disease modifying agents or immunosuppressive drugs within 6 months.
• History of noninfectious pneumonitis requiring steroids.