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NCT04044430 · ClinicalTrials.gov registry record · Phase 1
Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04044430: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT04044430 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044430, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as 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 encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
Primary Outcome
Will be measured according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). The point estimate of the objective response rate (ORR) and its 95% confidence interval will be obtained.
Interventions
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- DRUG Binimetinib
- DRUG Encorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 1 |
Why NCT04044430 stopped before completion
NCT04044430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT04044430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04044430 about?
NCT04044430 is a clinical study titled "Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer". This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth...
What is the current status of trial NCT04044430?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2020-08-31. Estimated completion is 2022-07-31.
What interventions are being tested in trial NCT04044430?
The interventions under investigation include: Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04044430?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04044430's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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