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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 3
18 Years
Not Enrolling
Metastatic or Unresectable Cutaneous Melanoma

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Trial Information

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

Inclusion Criteria:

- Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC
Stage IIIC or IV)

- Presence of NRAS Q61 mutation in tumor tissue prior to randomization

- Naïve untreated patients or patients who have progressed on or after prior first-line
immunotherapy for unresectable locally advanced or metastatic melanoma

- Evidence of at least one measurable lesion as detected by radiological or
photographic methods

- Adequate bone marrow, organ function, cardiac and laboratory parameters

- Normal functioning of daily living activities

Exclusion Criteria:

- Any active/non-stable brain lesion

- Non-cutaneous melanoma

- History of or current evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or history of retinal degenerative disease.

Patients with washout period < 12 weeks from the last dose of ipilimumab or other

Previous chemotherapy for unresectable locally advanced or metastatic melanoma.

- History of Gilbert's syndrome

- Prior therapy with a MEK- inhibitor

- Impaired cardiovascular function or clinically significant cardiovascular diseases

- Uncontrolled arterial hypertension despite medical treatment

- HIV positive or active Hepatitis A or B

- Impairment of gastrointestinal function or gastrointestinal disease

- Patients with neuromuscular disorders that are associated with elevated CK.

- Pregnant or nursing (lactating) women

- Medical, psychiatric, cognitive or other conditions that may compromise the patient's
ability to understand the patient information, give informed consent, comply with the
study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

PFS is defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined by a Blinded Independent Review Committee (BIRC). The local Investigator's assessments will be used as supportive analyses.

Outcome Time Frame:

The final PFS analysis is expected approximately 16 months after FPFV.

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

May 2016

Related Keywords:

  • Metastatic or Unresectable Cutaneous Melanoma
  • Melanoma
  • Cutaneous melanoma
  • Skin disease
  • Skin cancer
  • Skin Neoplasms
  • Neoplasm Metastasis
  • Melanoma
  • Skin Neoplasms



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