LEE011 with MEK162 for NRAS mutant melanoma
A Phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma
The purpose of this protocol is to evaluate the effects of the combination of two drugs, LEE011 and MEK162, in melanoma (skin cancer), carrying specific alterations (also called mutated) in a gene called NRAS. The changes in NRAS gene may lead to cancer growth. This study will help to assess if patients with NRAS changes may be more responsive to treatment with LEE011 and MEK162. The study will identify the highest dose of LEE011 in combination with MEK162 that can be safely given to adults with certain cancers and furthermore, evaluate any changes in tumor size. This study will also help in understanding what the combination of LEE011 and MEK162 does to a patient's body, and will assess how the body clears the study drugs. For this reason, a number of pharmacokinetic (PK) blood samples will be collected during this study. This is a phase Ib/II study (a phase Ib dose escalation part followed by a phase II part). This means that the study drugs have shown promise in animal testing as well as single agents in humans, but have not been used as a combination in patients before. Approximately 80 patients will participate in this study.
Are you Eligible? (Inclusion Criteria)
This study is limited to patients with histologically or cytologically confirmed locally advanced or metastatic NRAS mutant melanoma.