The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma - NEMO

Array BioPharma Inc.0 个研究点目标入组 393 人开始时间: 2013年2月25日最近更新: 2019年11月25日

研究概览

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•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 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
•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

•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 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 exclusion criteria may apply.

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