mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

Conditions

• Advanced Esophageal Adenocarcinoma
• Advanced Gastric Adenocarcinoma
• Advanced Gastroesophageal Junction Adenocarcinoma
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Gastric Cancer AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Metastatic Esophageal Adenocarcinoma
• Metastatic Gastric Adenocarcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Unresectable Esophageal Adenocarcinoma
• Unresectable Gastric Adenocarcinoma
• Unresectable Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorouracil — DRUG
  Given IV
• Leucovorin Calcium — DRUG
  Given IV
• Oxaliplatin — DRUG
  Given IV
• Irinotecan — DRUG
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Computed Tomography — PROCEDURE
  Undergo a CT Scan
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Key Dates

Start date

Jan 31, 2023

Status verified

May 2026

Primary completion

Nov 8, 2028

Completion

Nov 8, 2028

Study Design

Enrollment

382 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (mFOLFIRINOX, nivolumab)
  Patients receive fluorouracil IV, leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
• Active Comparator: Arm II (mFOLFOX, nivolumab)
  Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 2 years from the time of randomization. ]

Central Contacts

• Aishwarya Vijendran
  773-834-9613
  [email protected]

Locations (785)