|MDACC Study No:||2012-0976 (clinicaltrials.gov NCT No: NCT01767454)|
|Title:||Phase 1 Study of the BRAF Inhibitor Dabrafenib +/- MEK|
Inhibitor Trametinib in Combination with Ipilimumab for
V600E/K Mutation Positive Metastatic or Unresectable
|Principal Investigator:||Michael Davies|
|Treatment Agent:||GSK1120212 ; GSK2118436; Ipilimumab|
|Study Description:||The goal of this clinical research study is to find the highest tolerable dose |
of the combination of dabrafenib and ipilimumab that can be given with or
without trametinib to patients with metastatic melanoma that is positive for
the BRAF mutation. Mutations are abnormal changes in the DNA, the genetic
material in the cells of the body.
Dabrafenib is designed to block the mutated BRAF protein. By blocking the
protein, the drug may slow the growth of or kill cancer cells that have the
Trametinib is designed to block certain proteins that cause cancer cells to
grow and multiply. This may cause the cancer cells to die, especially in cells
with BRAF mutation.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
The drug blocks a molecule that is believed to shut down the part of the immune
system that attacks cancer cells.