EUCTR2017-003038-98-IT进行中（未招募）1 期
An evaluation of the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib. - NA
INTERGRUPPO MELANOMA ITALIANO0 个研究点目标入组 120 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- 性别
- All
入选标准
- •- Patients with histologically confirmed melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition;
- •- Patients previously untreated for metastatic melanoma;
- •- Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) by a validated mutational test;
- •- Adequate performance status to receive vemurafenib and cobimetinib therapy as determined by treating physician.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Cancer-related exclusion criteria:
- •1. Palliative radiotherapy within 7 days prior to the first dose of program treatment.
- •2. Patients with active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years except for patients with resected melanoma, resected BCC, resected cutaneous SCC, resected melanoma in situ, resected carcinoma in situ of the cervix, and resected carcinoma in situ of the breast.
- •Exclusion criteria based on organ function:
- •3. Evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment / central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration.
- •4. Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
- •5. History of clinically significant cardiac dysfunction, including the following:
- •a) Current unstable angina.
- •b) Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
- •c) History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF = 450 msec at baseline; presence of clinically significant ventricular or atrial dysrhythmias = Grade 2.
- •d) Uncontrolled hypertension = Grade 2 (patients with a history hypertension controlled with anti-hypertensives to = Grade 1 are eligible).
- •e) Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.
- •General exclusion criteria:
- •6. Current severe, uncontrolled systemic disease.
- •7. Major surgery or traumatic injury within 14 days prior to first dose of program treatment.
- •8. History of malabsorption or other condition that would interfere with absorption of program drugs.
- •9. Hypersensitivity to the active substance or to any of the excipients.
- •10. Pregnant or breastfeeding women.
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