Study comparing the efficacy of MEK162 versus dacarbazine in unresectable or metastatic NRAS mutation-positive melanoma (NEMO)

Phase 1

• Conditions: metastatic or unresectable cutaneous melanoma; MedDRA version: 20.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003593-51-AT
• Lead Sponsor: Array BioPharma inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 393

Inclusion Criteria

•Diagnosis of locally advanced, unresectable or metastatic cutaneous or unknown primary melanoma (AJCC Stage IIIC or IV) (Uveal and mucosal melnaoma are excluded)
•Presence of NRAS Q61 mutation in tumor tissue prior to randomization
•Naïve untreated patients or patients who have progressed on or after prior treatment with any number of lines of immunotherapy for unresectable 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

Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

• Any untreated/non-stable brain lesion
• Uveal or mucosal melanoma
• History of or current evidence of retinal vein occlusion (RVO)
• Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
• Any previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma
Note: chemotherapy given as part of isolated limb perfusion, regional or intralesional treatment will not be considered systemic treatment
• 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 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 exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified