Combined BRAF-Targeted Therapy & Immunotherapy for Melanoma
Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
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.