Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Objective Response Rate
研究概览
简要总结
This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.
The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IV or unresectable Stage III advanced melanoma
- •Prior treatment with at least 2 months of anti-PD-(L)1 agent
- •Measurable disease at baseline
- •Tumor available for biopsy
排除标准
- •History of allergy or severe hypersensitivity to biologic agents
- •History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
- •Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
研究组 & 干预措施
FLX475 and ipilimumab combination therapy
Participants received FLX475 tablets orally and ipilimumab by IV infusions
干预措施: FLX475 (Drug)
FLX475 and ipilimumab combination therapy
Participants received FLX475 tablets orally and ipilimumab by IV infusions
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Approximately 1 year
To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
时间窗: Approximately 3 weeks
Number of participants that experienced Other Adverse Events
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
时间窗: Approximately 3 weeks
Number of participants that experienced Serious Adverse Events
次要结局
- Progression-free Survival(Approximately 1 year)
- Overall Survival (OS)(Approximately 1 year)
- Plasma Concentrations of FLX475(Approximately 1 year)
- Pharmacodynamic (PD) Markers(Approximately 1 year)
- Tumor Control(Approximately 1 year)