mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
On this site
📄 Opdivo (nivolumab) drug profile →More Alliance for Clinical Trials in Oncology trials in Mexico
Other trials for the same condition
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