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NCT03776487 · ClinicalTrials.gov registry record · Phase 2
Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
A Phase 2 study of Gastric Adenocarcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03776487 is a Phase 2 study of Gastric Adenocarcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03776487, a Phase 2 study of Gastric Adenocarcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses thin beams of radiation of different strengths aimed at the tumor from many angles. This type of radiation therapy may reduce the damage to healthy tissue near the tumor. Giving nivolumab, ipilimumab, chemotherapy and radiation therapy may work better in treating patients with gastric cancer.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- BIOLOGICAL Nivolumab
- RADIATION Intensity-Modulated Radiation Therapy
- BIOLOGICAL Ipilimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03776487
The ClinicalTrials.gov registry entry for NCT03776487 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (87% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT03776487 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03776487 about?
NCT03776487 is a clinical study titled "Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer". This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, ...
What is the current status of trial NCT03776487?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-01-07. Estimated completion is 2026-12-30.
What conditions does trial NCT03776487 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT03776487?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Nivolumab (BIOLOGICAL), Intensity-Modulated Radiation Therapy (RADIATION), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03776487?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03776487 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.