NL-OMON47344已完成3 期
A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIc) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma (MEK115306) - MEK115306
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Subjects with histologically confirmed advanced or metastatic melanoma
- •* BRAF V600 E/K mutation positive.
- •* Measurable disease.
- •* 18 years and above.
- •* ECOG Performance Status 0-1.
- •* Females of childbearing potential: adequate method of contraception.
排除标准
- •* Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
- •* Prior systemic anti-cancer treatment for Stage IIIC or Stage IV melanoma.
- •* Brain metastases (exceptions see protocol page 26).
- •* Cardiovascular risk (see protocol page 26 for details).
- •* A history or current evidence/risk of retinal vein occlusion or central serous retinopathy.
- •* Pregnancy or breastfeeding
研究者
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