EUCTR2012-003593-51-SE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 393
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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