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Active, not recruiting Phase 2 Interventional

A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer

ClinicalTrials.gov ID: NCT04757363

Public ClinicalTrials.gov record NCT04757363. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 7:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of Nivolumab in Combination With FOLFOX and Regorafenib in Patients With HER2-Negative Metastatic Esophagogastric Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04757363
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
39 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2021
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027
Last update posted
Mar 3, 2026

2021 – 2027

United States locations

U.S. sites
7
U.S. states
2
U.S. cities
7
Facility City State ZIP Site status
Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Basking Ridge New Jersey 07920
Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey 07748
Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale New Jersey 07645
Memorial Sloan Kettering Commack (All Protocol Activities) Commack New York 11725
Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York 10065
Memorial Sloan Kettering Nassau (All Protocol Activities) Uniondale New York 11553

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04757363, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04757363 live on ClinicalTrials.gov.

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