A Phase 1 Study of the Safety and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination With Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab, BMS-734016) in Advanced and/or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Incidence of death
研究概览
简要总结
The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
- •Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
- •The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Participants with untreated central nervous system (CNS) metastases
- •Participants with an active, known, or suspected autoimmune disease
- •Uncontrolled or significant cardiovascular disease
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of death
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of dose-limiting toxicity (DLT)
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of adverse events (AEs)
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of AEs leading to discontinuation
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of serious adverse events (SAEs)
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Frequency of laboratory test toxicity grade shifting from baseline
时间窗: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
次要结局
- Incidence of dose-limiting toxicity (DLT)(Up to two years)
- Incidence of anti-drug antibody (ADA)(Up to two years)
- Volume of distribution at steady state (Vss)(Up to two years)
- Frequency of laboratory test toxicity grade shifting from baseline(Up to two years)
- Best overall response (BOR)(Up to two years)
- Duration of response (DOR)(Up to two years)
- Incidence of serious adverse events (SAEs)(Up to two years)
- Incidence of death(Up to two years)
- Incidence of adverse events (AEs)(Up to two years)
- Incidence of AEs leading to discontinuation(Up to two years)
- Clearance (CL)(Up to two years)
- Maximum serum observed concentration (Cmax)(Up to two years)
- Time of maximum observed serum concentration (Tmax)(Up to two years)
- Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)](Up to two years)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)](Up to two years)
- Trough observed serum concentration (Ctrough)(Up to two years)
- Area under the serum concentration-time curve in one dosing interval [AUC(TAU)](Up to two years)
- Ratio of an exposure measure at steady-state to that after the first dose (AI)(Up to two years)
- Half-life (T-HALF)(Up to two years)
- Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)(Up to two years)