A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects.
Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be administered orally in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated.
- •Have NRAS mutation.
- •Have at least one measurable lesion at baseline per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Age of 19 years or older
- •Adequate renal, hematologic and liver function.
排除标准
- •Have a history of prior treatment with RAF, MEK, or ERK inhibitor.
- •Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
- •Have past history or ongoing cardiac function-related disorders.
- •Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).
研究组 & 干预措施
Belvarafenib + Cobimetinib
Belvarafenib in combination with Cobimetinib
干预措施: Belvarafenib (Drug)
Belvarafenib + Cobimetinib
Belvarafenib in combination with Cobimetinib
干预措施: Cobimetinib (Combination Product)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Central Review (ICR)
次要结局
- Disease Control Rate (DCR)(Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years))
- Duration of response (DOR)(Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years))
- Progression-free survival (PFS)(Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years))
- Time to progression (TTP)(Throughout the study until disease progression (up to approximately 3 years))
- Overall survival (OS)(Throughout the study until the date of death (up to approximately 3 years))