A Phase II Study of LEE011 plus MEK162 in Patients with NRAS-Mutant Melanoma

Protocol
13-102
Full Title
A Phase Ib/II, Multicenter, Open Label, Study of LEE011 in Combination with MEK162 in Adult Patients with NRAS Mutant Melanoma
Phase
I/II
Purpose

MEK162 and LEE011 are investigational anticancer drugs being assessed together in this study in patients with melanoma. MEK162 blocks a protein called MEK, which can cause melanoma to grow. LEE011 blocks a protein called CDK, which tells melanoma cells to divide.

The abnormal (mutated) form a protein called NRAS increases the growth of melanoma. Another clinical trial showed that MEK162 helped some patients with NRAS-mutant melanoma. Laboratory studies have suggested that MEK162 may be more effective against NRAS-mutant melanoma when it is given with LEE011.

The purpose of this study is to assess the safety and effectiveness of the combination of LEE011 and MEK162 when given in patients with locally advanced or metastatic NRAS-mutant melanoma. 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 locally advanced or metastatic melanoma that contains mutated NRAS.
  • At least 2 weeks must have passed since completion of prior therapy (4 weeks since biologic therapy, such as antibodies) and entry into the study.
  • Patients may not have previously received a MEK inhibitor.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4589.

Disease(s)
Melanoma
Locations
Related Diseases