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NCT04879368 · ClinicalTrials.gov registry record · Phase 3
RegoNivo vs Standard of Care Chemotherapy in AGOC
A Phase 3 study of Gastro-Oesophageal Cancer, sponsored by Australasian Gastro-Intestinal Trials Group.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04879368: Active Phase 3 study of Gastro-Oesophageal Cancer, sponsored by Australasian Gastro-Intestinal Trials Group.
NCT04879368 is a Phase 3 study of Gastro-Oesophageal Cancer that is active but no longer recruiting, run by Australasian Gastro-Intestinal Trials Group. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879368, a Phase 3 study of Gastro-Oesophageal Cancer, is active but no longer recruiting, sponsored by Australasian Gastro-Intestinal Trials Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.
Primary Outcome
To determine the effect of RegoNivo on overall survival (OS) (death from any cause) in the overall study population and in the Asian sub-population. Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date last known alive.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Regorafenib
- BIOLOGICAL Nivolumab
- DRUG Irinotecan
Study Locations (20)
New South Wales
- Coffs Harbour Health Campus - Coffs Harbour
- Concord Repatriation General Hospital - Concord
- St Vincent's Public Hospital - Darlinghurst
- Border Medical Oncology Research Unit - East Albury
- Gosford Hospital - Gosford
- St George Hospital - Kogarah
- Newcastle Private Hospital - New Lambton Heights
- Port Macquarie Base Hospital - Port Macquarie
- Prince of Wales Hospital - Randwick
- Royal North Shore Private Hospital - Sydney
- The Tweed Hospital - Tweed Heads
- Ballarat Oncology and Haematology Services - Wendouree
- Westmead Hospital - Westmead
Arizona
- Mayo Clinic Arizona - Scottsdale
California
- USC Norris - Los Angeles
Iowa
- Siouxland Regional Cancer Center - Sioux City
Kentucky
- St Elizabeth Healthcare - Edgewood
South Dakota
- Monument Health Rapid City Hospital - Rapid City
Washington
- Fred Hutchinson Cancer Research Centre - South Lake Union Clinic - Seattle
Northern Territory
- Royal Darwin Hospital - Tiwi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 3 |
What the registry record for NCT04879368 still lists
NCT04879368 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Gastro-Oesophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT04879368 names 20 study sites across 8 states, led by New South Wales, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04879368 about?
NCT04879368 is a clinical study titled "RegoNivo vs Standard of Care Chemotherapy in AGOC". To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.
What is the current status of trial NCT04879368?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2021-06-01. Estimated completion is 2026-06-01.
What conditions does trial NCT04879368 study?
This clinical trial studies the following conditions: Gastro-Oesophageal Cancer.
What interventions are being tested in trial NCT04879368?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Regorafenib (DRUG), Nivolumab (BIOLOGICAL), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT04879368?
This trial is sponsored by Australasian Gastro-Intestinal Trials Group, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04879368 being conducted?
This trial has 20 study locations across Arizona, California, Iowa, Kentucky, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04879368's enrollment target sits among peer trials
450 838th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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