EUCTR2018-000168-27-LT进行中（未招募）1 期
COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus) - COMBI-APlus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Completely resected histologically confirmed cutaneous melanoma
- •stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]
- •V600E/K mutation positive using a validated local test
- •Subjects presenting with initial resectable lymph node recurrence after
- •a diagnosis of Stage I or II melanoma are eligible.
- •Patients who have previously had Stage III melanoma at any time are
- •not eligible
- •Recovered from definitive surgery (e.g. no uncontrolled wound
- •infections or indwelling drains).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •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 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Uveal or mucosal melanoma
- •Evidence of metastatic disease including unresectable in-transit
- •Received any prior adjuvant or neoadjuvant treatment, including but not limited to
- •chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF
- •and/or MEK inhibitors], biologic therapy, vaccine therapy,
- •investigational treatment, or radiotherapy for melanoma
- •Malignant disease, other than that being treated in this study.
- •Exceptions to this exclusion include the following: malignancies that
- •were treated curatively and have not recurred within 2 years prior to
- •study treatment; completely resected basal cell and squamous cell skin
- •cancers and any completely resected carcinoma in situ
- •History or current evidence of cardiovascular risk
- •A history or current evidence/risk of retinal vein occlusion (RVO) or
- •central serous retinopathy
- •Other protocol-defined exclusion criteria may apply
研究者
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