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NCT01940809 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01940809: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01940809 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01940809, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating melanoma.
Primary Outcome
Presented with 90% confidence intervals calculated using exact binomial methods.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- DRUG Trametinib
- BIOLOGICAL Ipilimumab
- DRUG Dabrafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-08-28 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 1 |
Why NCT01940809 stopped before completion
NCT01940809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01940809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01940809 about?
NCT01940809 is a clinical study titled "Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery". This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ip...
What is the current status of trial NCT01940809?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-08-28. Estimated completion is 2022-03-04.
What interventions are being tested in trial NCT01940809?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Trametinib (DRUG), Ipilimumab (BIOLOGICAL), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01940809?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01940809's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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