Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01813214 · ClinicalTrials.gov registry record · Phase 2
The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01813214 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 5 participants.
The verdict
NCT01813214, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is for patients with malignant melanoma which has spread beyond the local area and cannot be surgically removed, and who have melanoma tumors that are accessible for repeat biopsies. This research study is a way of gaining new knowledge about treatment options for metastatic melanoma. This research study is evaluating the effects of the drugs vemurafenib and cobimetinib on the immune system. Vemurafenib has been approved by the FDA for treatment of patients with advanced melanoma that harbors a B-RAF mutation. Vemurafenib works by blocking a protein called B-RAF. Researchers have found that a large number of melanomas have mutations (changes) in the BRAF gene. Genes are specific parts of your DNA that contain information on hereditary characteristics such as hair color and eye color. The BRAF gene codes for a protein called B-RAF, which is involved in sending signals in cells that can lead to cell growth. Research has determined that mutations in the BRAF gene at the V600 position cause a change in the B-RAF protein that can drive the growth and spread of melanoma cells. Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway. The purpose of this research study is to determine how vemurafenib and cobitmetinib may alter the immune system's reaction to melanoma, in order to learn how best to combine immune therapies with vemurafenib in the future.
Interventions
- DRUG Vemurafenib
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01813214
The ClinicalTrials.gov registry entry for NCT01813214 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.
NCT01813214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01813214 about?
NCT01813214 is a clinical study titled "The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma". This study is for patients with malignant melanoma which has spread beyond the local area and cannot be surgically removed, and who have melanoma tumors that are accessible for repeat biopsies. This research study is a way of gaining new knowledge about treatment options for metastatic melanoma. Thi...
What is the current status of trial NCT01813214?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01813214?
The interventions under investigation include: Vemurafenib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT01813214?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.