What is this trial studying for advanced HER2 negative esophageal and gastric cancers?

This trial is studying whether adding irinotecan to the standard chemotherapy regimen, with or without the immunotherapy drug nivolumab, can improve overall survival and other treatment outcomes in advanced HER2 negative esophageal, gastroesophageal junction, and gastric cancers. It is led by the Alliance for Clinical Trials in Oncology to compare these treatment approaches in patients with these cancers.

Who may be eligible for this advanced esophageal and gastric cancer clinical trial?

Adults aged 18 years and older with HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma that is unresectable or metastatic may be eligible. Participants must have good performance status and meet specific blood count and organ function criteria. Patients should not have had prior treatment for metastatic disease and must not have certain autoimmune conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced esophageal and gastric cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05677490

Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2 Negative Gastroesophageal Adenocarcinoma

Led by Alliance for Clinical Trials in Oncology · Updated on 2026-05-08

382

Participants Needed

792

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two chemotherapy combinations, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for treating advanced, unresectable, or metastatic HER2 negative cancers of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine if overall survival improves with mFOLFIRINOX compared to mFOLFOX and to assess differences in progression-free survival, response rates, safety, and patient-reported outcomes. Participants are randomly assigned to one of two groups one receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan intravenously, with nivolumab given as needed the other group receives fluorouracil, leucovorin calcium, and oxaliplatin intravenously, also with nivolumab as indicated. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional research on markers like PD-L1 combined positive score and cell-free DNA. During the study, participants will have regular imaging scans and blood collections to monitor their cancer and treatment effects. Researchers will track overall survival for up to two years and monitor progression-free survival, tumor response, duration of response, and adverse events for up to three years. Patient-reported outcomes will be collected at baseline and throughout treatment cycles to assess tolerability and side effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologic confirmation of HER2 negative adenocarcinoma with known PD-L1 combined positive score
Unresectable or metastatic stage of cancer
Tumor located in esophagus, gastroesophageal junction, or stomach
Measurable or evaluable disease as defined by RECIST 1.1
No previous treatment for unresectable or metastatic disease
Prior neoadjuvant or adjuvant chemotherapy or immunotherapy completed at least 1 year before enrollment
Age 18 years or older
ECOG Performance Status 0 or 1
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 30 mL/min
Total bilirubin ≤ 1.5 times upper limit of normal
AST and ALT ≤ 3 times upper limit of normal (≤ 5 times if liver metastases)
Patients with prior or concurrent malignancies that do not interfere with study assessments
HIV positive patients on effective treatment with undetectable viral load within 6 months
Cardiac function classified as New York Heart Association class 2B or better
No contraindications to immune checkpoint inhibitors if receiving nivolumab
Ability to speak, understand, and read English, Spanish, Korean, Chinese (Simplified), or Russian

You will not qualify if you...

Pregnant or nursing women; negative pregnancy test required for women of childbearing potential
Known Gilbert's syndrome or homozygosity for UGAT1A1*28 polymorphism
Baseline grade 2 or higher peripheral neuropathy or neurosensory/motor toxicity
Uncontrolled infection or uncontrolled diabetes mellitus
Untreated, symptomatic brain metastases; treated brain metastases must have stable imaging and steroid use
History of allogeneic tissue or organ transplant
Active autoimmune disease requiring systemic treatment within 6 months
Systemic corticosteroids or immunosuppressive medications within 14 days before registration (except low-dose steroids)

Research Team

Aishwarya Vijendran

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