CLINICAL TRIAL SUMMARY

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
Melanoma
Principal Investigator:Michael Davies
Treatment Agent:GSK1120212 ; GSK2118436; Ipilimumab
Study Status:Open
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
protein.

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.

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Disease Group:Melanoma
Phase of Study:Phase I
Treatment Agents:GSK1120212
GSK2118436
Ipilimumab
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Glaxo Smith-Kline
Return Visit:
Home Care:


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Physician Name:Michael Davies
Dept:Melanoma Medical Oncology
For Clinical Trial Enrollment:713-792-2921
For General Questions about Clinical Trials:1-877-MDA-6789


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