A Phase II Study of LEE011 plus LGX818 in Patients with BRAF-Mutant Melanoma

Protocol
13-097
Full Title
A Phase Ib/II, Multicenter, Study of LEE011 in Combination with LGX818 in Adult Patients with BRAF Mutant Melanoma
Phase
I/II
Purpose

LGX818 and LEE011 are investigational anticancer drugs being assessed together in this study in patients with melanoma. LGX818 blocks the activity of an abnormal form of a protein called BRAF, which promotes the growth of melanoma. LEE011 blocks a protein called CDK, which tells melanoma cells to divide. LGX818 may be more effective against melanoma when given in combination with LEE011.

The purpose of this study is to assess the safety and effectiveness of the combination of LEE011 and LGX818 when given in patients with locally advanced or metastatic BRAF-mutant melanoma whose cancers continued to grow despite prior therapy with a BRAF inhibitor. 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 a V600 BRAF mutation and continued to grow despite prior treatment with a BRAF inhibitor.
  • 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 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