EUCTR2016-002794-35-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 538
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
- •Part 1: Safety run-in
- •Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- •Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
- •ECOG performance status = 1
- •Part 2: Biomarker cohort
- •Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- •At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
- •ECOG performance status = 2
- •Part 3: Double-blind, randomized, placebo-controlled part
- •Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- •ECOG performance status = 2
- •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 409
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 129
排除标准
- •Part 1: Safety run-in
- •Subjects with uveal or mucosal melanoma
- •Any history of CNS metastases
- •Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
- •Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
- •Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
- •Radiation therapy within 4 weeks prior to start of study treatment
- •Active, known, suspected or a documented history of autoimmune disease
- •Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebocontrolled part
- •Subjects with uveal or mucosal melanoma
- •Clinically active cerebral melanoma metastasis
- •Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
- •Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
- •Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
- •Radiation therapy within 4 weeks prior to start of study treatment
- •Active, known, suspected or a documented history of autoimmune disease
- •Other protocol-defined Exclusion may apply.
研究者
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