Ireland
--:--IST
Recruiting Phase 3

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

NCT05677490 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2023-01-31
Last updated
2026-11-03

Condition(s) studied

Advanced Esophageal AdenocarcinomaAdvanced Gastric AdenocarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Esophageal AdenocarcinomaMetastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaUnresectable Esophageal AdenocarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

Fluorouracil →Leucovorin Calcium →Oxaliplatin →Irinotecan →Nivolumab →Magnetic Resonance ImagingComputed TomographyBiospecimen CollectionQuestionnaire Administration

Fluorouracil: Given IV

Leucovorin Calcium: Given IV

Oxaliplatin: Given IV

Irinotecan: Given IV

Nivolumab: Given IV

Magnetic Resonance Imaging: Undergo MRI

Computed Tomography: Undergo a CT Scan

Biospecimen Collection: Undergo blood sample collection

Questionnaire Administration: Ancillary studies

Study summary

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 chemotherapy. The usual approach is defined as care most people get for cancer in the stomach, esophagus, or gastroesophageal junction. Fluorouracil is in a class of medications called antimetabolites. It stops cells from making DNA and may kill tumor cells. Leucovorin in a class of medications called folic acid analogs. When used with fluorouracil it enhances the effects of this chemotherapy drug. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair, and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Some patients on this trial will receive nivolumab, in addition to mFOLFOX or mFOLFIRINOX chemotherapy. mFOLFIRINOX with or without nivolumab may be more effective than mFOLFOX with or without nivolumab by shrinking the tumor in patients with advanced, unresectable, or metastatic HER2-negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology \[JCO\] 2017) with known PD-L1 combined positive score (CPS) (any CPS is allowed, but should be known prior to registration) * 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 * No prior systemic treatment for unresectable or metastatic disease * Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \* Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min * Total bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (in patients with liver metastasis: =\< 5 x ULN if clearly attributable to liver metastases) * 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 of the investigational regimen are eligible for this trial * Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following: * On effective anti-retroviral therapy * Undetectable HIV viral load by standard clinical assay =\< 6 months of registration * No known Gilbert's syndrome or known homozygosity for UGAT1A1\*28 polymorphism * No baseline grade \>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality * No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks * No allogeneic tissue/organ transplant * Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors * Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Patients must not have a condition requiring systemic treatment with either corticosteroids (\>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=\< 10mg/day prednisone equivalent) are permitted * Patients must not have a history of noninfectious pneumonitis requiring steroids * Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible

Primary outcome measure(s)

  • Overall survival (OS) — Up to 2 years from the time of randomization.
    Will compare the distributions of OS between the two treatment arms to determine if patients treated with modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) (with or without nivolumab) have an OS benefit compared to those treated with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) (with or without nivolumab). Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. To compare the OS distributions between the two treatment arms, we will use a one-sided logrank test to evaluate if mFOLFIRINOX (with or without nivolumab) is superior to mFOLFOX (with or without nivolumab) based on an intention to treat analysis. The hazard ratio, median OS, and estimated OS rates at 1 and 2 years will be estimated along with corresponding 95% confidence intervals. Multivariable Cox proportional hazards models will also be used to assess the impact of treatment arm on OS when stratifying on the stratification factors.

Trial sites (802)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Active Not Recruiting
Anchorage Associates in Radiation Medicine Anchorage Alaska Recruiting
Anchorage Radiation Therapy Center Anchorage Alaska Suspended
Alaska Breast Care and Surgery LLC Anchorage Alaska Recruiting
Alaska Oncology and Hematology LLC Anchorage Alaska Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Anchorage Oncology Centre Anchorage Alaska Suspended
Katmai Oncology Group Anchorage Alaska Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Fairbanks Memorial Hospital Fairbanks Alaska Recruiting
Kingman Regional Medical Center Kingman Arizona Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Active Not Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CARTI Cancer Center Little Rock Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Active Not Recruiting
PCR Oncology Arroyo Grande California Recruiting
Sutter Auburn Faith Hospital Auburn California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California Recruiting
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Mills-Peninsula Medical Center Burlingame California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Active Not Recruiting
Mercy San Juan Medical Center Carmichael California Active Not Recruiting
Eden Hospital Medical Center Castro Valley California Recruiting
UC Irvine Health Cancer Center-Newport Costa Mesa California Recruiting
Sutter Davis Hospital Davis California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Active Not Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Palo Alto Medical Foundation-Fremont Fremont California Recruiting
Fresno Cancer Center Fresno California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Keck Medicine of USC Koreatown Los Angeles California Recruiting
Los Angeles General Medical Center Los Angeles California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
Contra Costa Regional Medical Center Martinez California Active Not Recruiting

+ 762 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05677490 on ClinicalTrials.gov ↗ ← All trials in Mexico