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NCT04757363 · ClinicalTrials.gov registry record · Phase 2
A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer
A Phase 2 study of Esophagogastric Cancer and HER2-Negative, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 7
- Study locations
NCT04757363: Active Phase 2 study of Esophagogastric Cancer and HER2-Negative, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04757363 is a Phase 2 study of Esophagogastric Cancer and HER2-Negative that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 39 participants, below the 75-participant average among 5 other Esophagogastric Cancer trials with a reported enrollment target (48% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04757363, a Phase 2 study of Esophagogastric Cancer and HER2-Negative, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
will be defined according to RECIST 1.1.
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 |
What the registry record for NCT04757363 still lists
NCT04757363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 75-participant average among 5 other Esophagogastric Cancer trials with a reported enrollment target (48% lower).
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.
NCT04757363 lists 7 locations in 2 states (New York, New Jersey).
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.
What interventions are being tested in trial NCT04757363?
The interventions under investigation include: nivolumab (DRUG), regorafenib (DRUG), FOLFOX chemotherapy with oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT04757363?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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.
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