NCT03745807已完成1 期
A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年4月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.
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
- 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
- •Inclusion Criteria:
- •Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.
- •Life expectancy >12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Active, known or suspected autoimmune disease.
- •History of organ transplant that requires use of immune suppressive agents.
- •Prior surgery or radiotherapy within 14 days of Cycle 1 Day
- •Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Combination
Experimental
NKTR-214 + nivolumab
干预措施: NKTR-214 (Biological)
Combination
Experimental
NKTR-214 + nivolumab
干预措施: Nivolumab (Biological)
结局指标
主要结局
Incidence of AEs leading to discontinuation
时间窗: Approximately 2 years
Incidence of laboratory abnormalities
时间窗: Approximately 2 years
Incidence of adverse events (AEs)
时间窗: Approximately 2 years
Incidence of serious adverse events (SAEs)
时间窗: Approximately 2 years
Incidence of deaths
时间窗: Approximately 2 years
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
时间窗: Approximately 2 years
次要结局
- Duration of response (DOR)(Approximately 2 years)
- Maximum observed concentration (Cmax)(Approximately 2 years)
- Incidence of anti-drug antibodies (ADA) to NKTR-214(Approximately 2 years)
- Incidence of anti-drug antibodies (ADA) to nivolumab(Approximately 2 years)
- Total body clearance (CLT)(Approximately 2 years)
- Volume of distribution (Vz)(Approximately 2 years)
- Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)](Approximately 2 years)
- Time of maximum observed concentration (Tmax)(Approximately 2 years)
- Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)](Approximately 2 years)
- Apparent terminal phase half-life (T-HALF)(Approximately 2 years)
- Trough observed serum concentration at the end of the dosing interval (Ctrough)(Approximately 2 years)
- Best overall response (BOR)(Approximately 2 years)
研究者
研究点 (1)
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