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

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX

Trial Details

NCT ID

NCT05677490

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Status

RECRUITING

Cancer Type

Gastric Cancer

Interventions

Fluorouracil
Leucovorin Calcium
Oxaliplatin
Irinotecan
Nivolumab
Magnetic Resonance Imaging

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists …
Stage: unresectable or metastatic
Tumor site: esophagus, gastroesophageal junction, or stomach
Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

For full eligibility, visit ClinicalTrials.gov.

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