A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- •IO therapy resistant or insensitive tumors
- •Have at least 2 tumor lesions accessible for biopsy
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
排除标准
- •Primary CNS malignancy
- •Participants with other active malignancy requiring concurrent intervention
- •Uncontrolled or significant cardiovascular disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A
BMS-986299
干预措施: BMS-986299 (Drug)
Arm B
BMS-986299 in combination with nivolumab and ipilimumab
干预措施: BMS-986299 (Drug)
Arm B
BMS-986299 in combination with nivolumab and ipilimumab
干预措施: Nivolumab (Biological)
Arm B
BMS-986299 in combination with nivolumab and ipilimumab
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
时间窗: Up to 28 days
Incidence of clinical laboratory abnormalities
时间窗: Approximately 2 years
Incidence of serious adverse events (SAEs)
时间窗: Approximately 2 years
Incidence of AEs leading to discontinuation and deaths
时间窗: Approximately 2 years
Incidence of adverse events (AEs)
时间窗: Approximately 2 years
次要结局
- Time of maximum observed plasma concentration (Tmax)(Approximately 2 years)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)](Approximately 2 years)
- Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)](Approximately 2 years)
- Maximum observed plasma concentration (Cmax)(Approximately 2 years)