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NCT01754376 · ClinicalTrials.gov registry record · Phase 2
Combined BRAF-Targeted Therapy & Immunotherapy for Melanoma
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01754376: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01754376 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01754376, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial of an investigational combination of drugs (vemurafenib and aldesleukin) to learn whether the combination works in treating a specific cancer. While both vemurafenib and aldesleukin are approved by the FDA for the treatment of metastatic melanoma, the FDA has not yet approved the combination of vemurafenib and aldesleukin. Researchers have found that a large number of melanoma cells have mutations in the BRAF gene. It has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene, and, as a result, may help to prevent cancer growth. Aldesleukin, also referred to as IL-2, is an immunotherapy drug administered via IV infusion that increases the growth of key cells within the immune system that are responsible for targeting cancer cells. Activating more of these key cells, called T-lymphocytes and natural-killer cells, leads to increased cancer cell death. The BRAF gene is located on a larger pathway called the MAPK pathway. Studies have shown that when a BRAF inhibitor, like vemurafenib is used to block the MAPK pathway, melanocytes, or cancer cells express more proteins on their surfaces, making them easier for T-lymphocytes and natural killer cells to recognize and kill them. This suggests that combining BRAF-targeted therapy with aldesleukin, which activates more of these white blood cells, can lead to an increase in the death of cancer cells. In this research study, the investigators are looking to see whether the combination of vemurafenib (a BRAF-inhibitor) combined with aldesleukin(an immunotherapy drug) work together to produce a better health outcome in people with metastatic melanoma.
Primary Outcome
To assess the efficacy (as measured by progression-free survival (PFS)) of patients with metastatic melanoma with V600E mutation treated with the combination of vemurafenib and aldesleukin. Progression free survival is defined as the time between the first dose of study drug and the first occurrence of progression of disease or death from any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), as at least a 20% increase in the sum of the diameters of
Interventions
- DRUG Aldesleukin
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Why NCT01754376 stopped before completion
NCT01754376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin is the first listed.
NCT01754376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01754376 about?
NCT01754376 is a clinical study titled "Combined BRAF-Targeted Therapy & Immunotherapy for Melanoma". This research study is a Phase II clinical trial of an investigational combination of drugs (vemurafenib and aldesleukin) to learn whether the combination works in treating a specific cancer. While both vemurafenib and aldesleukin are approved by the FDA for the treatment of metastatic melanoma, the...
What is the current status of trial NCT01754376?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2013-01. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01754376?
The interventions under investigation include: Aldesleukin (DRUG), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01754376?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01754376's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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