Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05677490 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
Started2023-01-31
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Contacts/Locations v18
Study sitesdetails revised at 20 of 793 sites
2026-08-31
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v17
Eligibility criteria-317 characters
[...] , Journal of Clinical Oncology [JCO] 2017) with known PD-L1 CPScombined positive score (AnyCPS) (any CPS is allowed, but should be known prior to registration) [...] se Evaluation Criteria in Solid Tumors (RECIST) 1.1 No prior systemic treatment for unresectable or metastatic disease Prior neoa [...] g as it was completed at least 1 year prior to registration ⇅ moved Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects ⇅ moved * Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to regi [...] [...]
Study sitesdetails revised at 1 of 793 sites
2026-08-04
Study Status, Contacts/Locations v16
Study sites794→793
2026-07-01
Study Status, Contacts/Locations v15
Study sites792→794
2026-05-07
Study Status, Contacts/Locations v14
Study sites791→792
2026-04-06
Study Status, Contacts/Locations v13
Trial sites expanded: 786 → 791 locations
2026-03-02
Study Status, Contacts/Locations v12
Study sites783→786
2026-02-03
Study Status, Contacts/Locations v11
Study sites782→783
2026-01-06
Study Status, Contacts/Locations v10
Study sites780→782
2025-12-08
Study Status, Contacts/Locations v9
Study sites778→780
2025-11-04
Study Status, Contacts/Locations v8
Study sites777→778
2025-10-07
Study Status, Contacts/Locations v7
Study sites756→777
2025-03-28
Study Identification, Study Status, Conditions, Contacts/Locations, IPDSharing v6
Study sites735→756
Study titlerevised
MFOLFIRINOXmFOLFIRINOX Versus MFOLFOXmFOLFOX withWith or Without Nivolumab for the Treatment of Advanced, Unresec [...]
2025-01-09
Study Identification, Study Status, Conditions, Contacts/Locations, IPDSharing v5
Start date2023-01-23→2023-01-31
Study sitesdetails revised at 690 of 735 sites
Study titlerevised
mFOLFIRINOXMFOLFIRINOX Versus mFOLFOXMFOLFOX Withwith or Without Nivolumab for the Treatment of Advanced, Unresec [...]
2024-10-24
Study Status, Contacts/Locations v4
Study sites564→735
2023-08-30
Study Status, Contacts/Locations v3
Study sites548→564
2023-08-18
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2023-07-10
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01-06→confirmed 2023-01-23
Study sites0→548
2023-01-03
Original filing
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.
Trial Details
NCT Number NCT05677490
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8 +7 more
Enrollment 382 participants
Start Date 2023-01-31
Primary Completion 2028-11-08 (estimated)
Study Completion 2028-11-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-03