Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer
NCT04757363 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to find out whether combining nivolumab, FOLFOX, and regorafenib may be a safe and effective treatment for people who have HER2-negative metastatic esophagogastric cancer. Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm. Nivolumab blocks the protein PD-1 (programmed cell death receptor-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them. FOLFOX is a combination of three standard chemotherapy drugs (leucovorin, 5-fluorouracil, and oxaliplatin) commonly used to treat your type of cancer. The drugs work by damaging the DNA in cancer cells, which can cause the cells to stop growing and die. Regorafenib is a type of drug called a tyrosine kinase inhibitor (TKI). This drug targets the tyrosine kinase protein found in or on the surface of cancer cells that the cells need to survive and grow. Blocking this protein may stop cancer cells from growing, or cause them to grow more slowly or to shrink. The study researchers think that combining nivolumab, FOLFOX, and regorafenib may be a more effective treatment for HER2-negative metastatic esophagogastric cancer than the usual chemotherapy treatment(s) alone.
Conditions Studied
Interventions
- DRUG nivolumab
- DRUG regorafenib
- DRUG FOLFOX chemotherapy with oxaliplatin
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (All Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04757363
The ClinicalTrials.gov registry entry for NCT04757363 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Esophagogastric Cancer appearing as the primary indexed condition, and to 3 interventions — of which nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04757363 reports 7 study locations spanning 2 distinct geographic areas — top geographies include New York, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04757363 about?
NCT04757363 is a clinical study titled "A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer". The purpose of this study is to find out whether combining nivolumab, FOLFOX, and regorafenib may be a safe and effective treatment for people who have HER2-negative metastatic esophagogastric cancer. Nivolumab is an antibody, like the proteins made by the immune system to protect the body from har...
What is the current status of trial NCT04757363?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2021-02-11. Estimated completion is 2027-02.
What conditions does trial NCT04757363 study?
This clinical trial studies the following conditions: Esophagogastric Cancer, HER2-Negative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04757363?
The interventions under investigation include: nivolumab (DRUG), regorafenib (DRUG), FOLFOX chemotherapy with oxaliplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04757363?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04757363 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.