mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jan 3, 2023
Trial Information
Current as of November 10, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two different chemotherapy treatments for patients with advanced or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric cancer. The trial is investigating whether a combination of chemotherapy drugs called mFOLFIRINOX, which includes irinotecan, is more effective than a more common treatment called mFOLFOX. Some patients may also receive an immunotherapy drug called nivolumab to help boost their immune response against the cancer. This trial aims to determine which treatment is better at reducing tumors and improving survival for patients who cannot have their cancer surgically removed.
To participate in this trial, patients must be at least 18 years old and have a specific type of cancer that cannot be treated with surgery. They should not have received any prior treatment for their advanced cancer. Other eligibility criteria include having a certain level of health as assessed by doctors, and patients must not have ongoing serious health issues that could complicate their treatment. Those who join the trial can expect regular check-ups and treatment with the assigned chemotherapy, and they will be monitored closely to see how well the treatment is working. It's important to note that this study is still recruiting participants, so there are opportunities for eligible patients to get involved.
Gender
ALL
Eligibility criteria
- 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 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 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
- • 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
- • 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
- • 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
- • This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to speak, understand and read in these languages. Ad-hoc translation of patient-reported measures is not permitted
- Exclusion Criteria:
- • 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
- • 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
- • 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
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Thief River Falls, Minnesota, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Sleepy Hollow, New York, United States
Clemmons, North Carolina, United States
Dublin, Ohio, United States
Richardson, Texas, United States
Cudahy, Wisconsin, United States
Wilkesboro, North Carolina, United States
Fresh Meadows, New York, United States
New York, New York, United States
Missoula, Montana, United States
Greenlawn, New York, United States
Little Rock, Arkansas, United States
Napa, California, United States
Pierre, South Dakota, United States
Hayward, Wisconsin, United States
Spooner, Wisconsin, United States
Superior, Wisconsin, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
'Aiea, Hawaii, United States
Nampa, Idaho, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Lexington, Kentucky, United States
Sheboygan, Wisconsin, United States
Yankton, South Dakota, United States
Fort Worth, Texas, United States
Kansas City, Missouri, United States
Kalispell, Montana, United States
Los Angeles, California, United States
Dallas, Texas, United States
Mount Sterling, Kentucky, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Pontiac, Michigan, United States
Pittsburg, Kansas, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Foxboro, Massachusetts, United States
Centralia, Illinois, United States
Dayton, Ohio, United States
Webster, New York, United States
Neillsville, Wisconsin, United States
Paducah, Kentucky, United States
San Juan, Puerto Rico
Danville, Illinois, United States
New Albany, Ohio, United States
Greenville, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Los Angeles, California, United States
Ames, Iowa, United States
Merced, California, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Ladysmith, Wisconsin, United States
Minocqua, Wisconsin, United States
Osage Beach, Missouri, United States
Ankeny, Iowa, United States
Rego Park, New York, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Tifton, Georgia, United States
O'fallon, Illinois, United States
Avon, Connecticut, United States
Manchester, Connecticut, United States
Des Moines, Iowa, United States
Lansing, Michigan, United States
Carmichael, California, United States
Rockford, Illinois, United States
Hays, Kansas, United States
Escanaba, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Lynchburg, Virginia, United States
Wilmington, Ohio, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Walnut Creek, California, United States
Irvine, California, United States
Dearborn, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
Mitchell, South Dakota, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Paducah, Kentucky, United States
Santa Cruz, California, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Wheat Ridge, Colorado, United States
Lafayette, Colorado, United States
Golden, Colorado, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Aurora, Illinois, United States
Brighton, Colorado, United States
Foxborough, Massachusetts, United States
Flint, Michigan, United States
Warren, Michigan, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Havre, Montana, United States
Denver, Colorado, United States
Olathe, Kansas, United States
Grosse Pointe Woods, Michigan, United States
Westminster, Colorado, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Aiea, Hawaii, United States
Aiea, Hawaii, United States
Macomb Township, Michigan, United States
Aiea, Hawaii, United States
Ewa Beach, Hawaii, United States
Denver, Colorado, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
Cherry Hill, New Jersey, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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