NCT04417621进行中（未招募）2 期
A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
- 试验地点
- 43
- 主要终点
- Overall Response Rate
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight > 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma
- •Previously treated for unresectable or metastatic melanoma:
- •Participants with NRAS mutation:
- •Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
- •A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents administered with CPI are permitted.
- •To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. Confirmation is not required for patients who remained on treatment for >6 months.
- •Participants with BRAFV600 mutant disease:
- •Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy.
- •A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted.
- •A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
- •Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
- •≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
- •≤ 2 weeks for small molecule therapeutics.
- •≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
- •≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
- •≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c.
- •Participants participating in additional parallel investigational drug or medical device studies.
- •All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
- •Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
LXH254 + LTT462
Experimental
干预措施: LXH254 (Drug)
LXH254 + LTT462
Experimental
干预措施: LTT462 (Drug)
LXH254 + trametinib
Experimental
干预措施: Trametinib (Drug)
LXH254 + ribociclib
Experimental
干预措施: Ribociclib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 35 months
Confirmed ORR using RECIST v1.1, per local assessment
次要结局
- Disease Control Rate (DCR)(3 years)
- Progression Free Survival (PFS)(4 years)
- Overall Survival (OS)(4 years)
- Derived PK parameter (Cmax) for LXH254 & trametinib(Up to 5 months)
- Derived PK parameter (AUC) for LXH254 & ribociclib(Up to 5 months)
- Duration of Reposnse (DOR)(4 years)
- Derived PK parameter (AUC) for LXH254 & LTT462(Up to 5 months)
- Dose reductions(35 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(35 months)
- Dose Interruptions(35 months)
- Derived PK parameter (AUC) for LXH254 & trametinib(Up to 5 months)
- Derived PK parameter (Cmax) for LXH254 & LTT462(Up to 5 months)
- Derived PK parameter (Cmax) for LXH254 & ribociclib(Up to 5 months)
研究者
研究点 (43)
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