Study Details

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Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab

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.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

This study has 2 study groups. • Group 1 If you are in this group, you will get FOLFOX, the two-drug chemotherapy. This treatment consists of the usual drugs used to treat this type of cancer and nivolumab (unless contraindicated). You will also get a drug called leucovorin that may help prevent side effects. Oxaliplatin and leucovorin will be given as an IV infusion over a 2-hour window on the first day of every cycle. Fluorouracil will be given as an IV bolus on the first day of the cycle and as an IV infusion over a 46-hour window on the first day of every cycle. If you get nivolumab, it will be given as an IV infusion over 30 minutes on the first day of every cycle. Each cycle is 14 days. • Group 2 If you are in this group, you will get mFOLFIRINOX, the three-drug chemotherapy. This treatment consists of the usual drugs used to treat this type of cancer (FOLFOX), and nivolumab (unless contraindicated), plus an additional chemotherapy drug, called irinotecan. You will also get a drug called leucovorin that may help prevent side effects, and drugs called blood cell growth factors that help the body make new blood cells and prevent infection.

In-person visits:
12

Total length of participation:
60 months

Looking for Specific Volunteers

Able to participate:

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
No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus

Not eligible if:

Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible
Patients with active autoimmune disease that has required systemic treatment within 6 months prior to registration
Untreated, symptomatic brain metastasis
Known Gilbert's Syndrome or known homozygosity

Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab

Age & Gender

Visit Availability

Location

What will be asked of you

Looking for Specific Volunteers

Able to participate:

Not eligible if:

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Additional Study Information

Principal Investigator

Study Type

Study Topics

IRB Number

ClinicalTrials.gov

Helpful Links

Questions?