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Study Comparing the Efficacy ...

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

Last Updated: 2021-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-12

Study Completion Date

2019-06-04

Brief Summary

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Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

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Detailed Description

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Conditions

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Metastatic or Unresectable Cutaneous Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEK162

Group Type EXPERIMENTAL

MEK162

Intervention Type DRUG

MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.

Dacarbazine

Group Type ACTIVE_COMPARATOR

Dacarbazine

Intervention Type DRUG

Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Interventions

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MEK162

MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.

Intervention Type DRUG

Dacarbazine

Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

Florida Cancer Specialists

Altamonte Springs, Florida, United States

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Florida Cancer Specialists

Bonita Springs, Florida, United States

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Florida Cancer Specialists

Bradenton, Florida, United States

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Florida Cancer Specialists

Brandon, Florida, United States

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Florida Cancer Specialists

Cape Coral, Florida, United States

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Florida Cancer Specialists

Clearwater, Florida, United States

Site Status

Florida Cancer Specialists

Clearwater, Florida, United States

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Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists

Gainesville, Florida, United States

Site Status

Florida Cancer Specialists

Hudson, Florida, United States

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Florida Cancer Specialists

Inverness, Florida, United States

Site Status

Florida Cancer Specialists

Largo, Florida, United States

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Florida Cancer Specialists

Largo, Florida, United States

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Florida Cancer Specialists

Naples, Florida, United States

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Florida Cancer Specialists

Naples, Florida, United States

Site Status

Florida Cancer Specialists

New Port Richey, Florida, United States

Site Status

Florida Cancer Specialists

Orange City, Florida, United States

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Florida Cancer Specialists

Orlando, Florida, United States

Site Status

Florida Cancer Specialists

Port Charlotte, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists

Spring Hill, Florida, United States

Site Status

Florida Cancer Specialists

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists

Tampa, Florida, United States

Site Status

Florida Cancer Specialists

Tampa, Florida, United States

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Florida Cancer Specialists

Tavares, Florida, United States

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Florida Cancer Specialists

Venice, Florida, United States

Site Status

Florida Cancer Specialists

Venice, Florida, United States

Site Status

Oncology Specialists, SC

Niles, Illinois, United States

Site Status

Oncology Specialists, SC

Park Ridge, Illinois, United States

Site Status

Goshen Center For Cancer Care

Goshen, Indiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

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Harry and Jeannette Weinberg Cancer Institute @Franklin Square

Baltimore, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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Kresge Eye Institute

Bingham Farms, Michigan, United States

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Kresge Eye Institute

Detroit, Michigan, United States

Site Status

Karmanos Cancer Institute of Farmington Hills

Farmington Hills, Michigan, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

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Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Cooper University Hospital

Voorhees Township, New Jersey, United States

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The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Site Status