RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/-NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Contact:

NCT Number:

Protocol:

AAAV1412

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

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 for patients who are not in a study is treatment with two chemotherapy drugs, 5-fluorouracil (5-FU) and oxaliplatin, called the FOLFOX regimen. Some patients receive an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy.

Are you Eligible? (Inclusion Criteria)

  • Age ≥ 18 years No treatment with in the passed year for unrepresentable or metastatic disease Have you been diagnosed with HER2 negative adenocarcinoma unresectable or metastatic gastroesophageal

Specialty Area(s)

Esophageal Cancer, Stomach Cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032