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NCT04362839 · ClinicalTrials.gov registry record · Phase 1
Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT04362839: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT04362839 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362839, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of regorafenib when given together with ipilimumab and nivolumab in treating patients with microsatellite stable colorectal cancer that has spread to other places in the body (metastatic) and remains despite chemotherapy treatment (resistant). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib, ipilimumab and nivolumab may slow the tumor growth and/or shrink the tumor size in patients with colorectal cancer.
Primary Outcome
Toxicities will be graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0. Dose limiting toxicity (DLT) will be graded per CTCAE v5.0. Any of the following adverse events occurring during the primary DLT observation period (4 weeks, from the time of first administration of regorafenib, ipilimumab and nivolumab\[cycle 1 day 1\] until the planned administration of the second cycle of regorafenib (cycle 2 day 1) that are at least probable
Interventions
- DRUG Regorafenib
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 1 |
What the finished NCT04362839 record still lists
NCT04362839 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Regorafenib is the first listed.
NCT04362839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362839 about?
NCT04362839 is a clinical study titled "Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer". This phase I trial studies the side effects and best dose of regorafenib when given together with ipilimumab and nivolumab in treating patients with microsatellite stable colorectal cancer that has spread to other places in the body (metastatic) and remains despite chemotherapy treatment (resistant)...
What is the current status of trial NCT04362839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2020-05-27. Estimated completion is 2025-12-11.
What interventions are being tested in trial NCT04362839?
The interventions under investigation include: Regorafenib (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04362839?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04362839's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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