A Phase III Study of MEK162 versus Dacarbazine in Patients with Inoperable or Metastatic Melanomas with NRAS Q61 Mutations: The NEMO Trial

Protocol
13-083
Full Title
The NEMO Trial (NRAS Melanoma and MEK Inhibitor): A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients with Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
Phase
III
Purpose

Mutations in the NRAS gene, such as the NRAS Q61 mutation, result in the production of an abnormal protein that can fuel the growth of melanoma. The purpose of this study is to compare the effectiveness of an investigational drug called MEK162 with a standard chemotherapy drug for melanoma, dacarbazine, in patients with inoperable stage III or metastatic (stage IV) melanomas that contain the NRAS Q61 mutation

MEK162 inhibits a protein called MEK1/2, which drives cancer growth. Preliminary evidence suggests that MEK162 may be effective against melanoma in patients with the NRAS Q61 mutation. In this study, patients will be randomly assigned to receive either MEK162 (two-thirds of the patients) or dacarbazine (the remaining third), but not both.

MEK162 is taken orally (by mouth), while dacarbazine is given intravenously.

Eligibility

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

  • Patients must have inoperable stage III or metastatic (stage IV) melanoma that contains the NRAS Q61 mutation.
  • At least 12 weeks must have passed since completion of previous ipilimumab therapy and entry into the study.
  • Patients may not have received prior MEK inhibitors, chemotherapy for stage III or IV disease, or more than one regimen of systemic therapy for metastatic melanoma.
  • 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 and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4589.

Disease(s)
Melanoma
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