Trial Search Results

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

The purpose of this study is to determine the effect of the study drug, MEK162 on advanced unresectable or metastatic NRAS mutation-positive melanoma. This study also aims to learn more about the safety and tolerability of MEK162.

MEK162 is a new drug that might be useful in treating patients with advanced melanoma. Melanoma often starts because of a mutation that changes normal skin pigment cells into cancer cells. One of the mutations, called NRAS, creates an unusually aggressive type of melanoma which is difficult to treat. If your melanoma has the NRAS mutation (a very specific type of advanced skin cancer), and your tumor is advanced and cannot be completely removed by surgery or is metastatic, then MEK162 may slow the growth of the tumor, or even make it smaller.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Stanford Investigator(s):

Intervention(s):

  • Drug: MEK162
  • Drug: Dacarbazine

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of
   unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)

   - Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by
   a Novartis designated central laboratory

   - Naïve untreated patients or patients who have progressed on or after any number of
   prior lines of 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 untreated CNS metastases

   - Uveal or mucosal melanoma

   - History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO

   - Patients with washout period < 6 weeks from the last dose of ipilimumab or other
   immunotherapy.

   - Previous systemic 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

   - Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting
   study drug or who have not recovered from side effects of such procedure;

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting