A Phase II Study of Trametinib with and without GSK2141795 in Patients with Advanced Uveal Melanoma

Protocol
13-144
Full Title
A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination with GSK2141795 in Patients with Advanced Uveal Melanoma (NCI #9445)
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drug trametinib given alone and in combination with GSK2141795 in patients with advanced uveal melanoma (a cancer of the eye) that cannot be cured by surgery. Trametinib is approved for treating advanced melanoma; it has been assessed thoroughly in patients with melanoma of the skin, but it has not been evaluated as well in uveal melanoma. Trametinib works by blocking a protein involved in cancer growth called MEK.

GSK2141795 is an investigational drug designed to inhibit cancer growth by blocking the activity of a protein called AKT. Patients will be randomly assigned to receive trametinib alone or trametinib plus GSK2141795. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic uveal melanoma that has not been previously treated with systemic therapies.
  • Patients may have received prior treatment with local therapies, such as radiofrequency ablation or cryotherapy, but must have completed those treatments at least 3 weeks before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Richard D. Carvajal at 646-888-4161.

Disease(s)
Melanoma: Melanoma of the Eye
Locations
Related Diseases