NCT03192943已完成1 期
A Phase 1 Study for Safety and Tolerability of BMS-986205 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 11 人开始时间: 2017年6月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Incidence of Laboratory Abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced 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
- •Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
- •Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting
- •Eastern Cooperative Oncology Group performance status of ≤ 1
排除标准
- •Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded
- •History of congenital or autoimmune hemolytic disorders
- •History or presence of hypersensitivity or idiosyncratic reaction to methylene blue
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Dose Escalation
Experimental
monotherapy and combination therapy
干预措施: BMS-986205 (Drug)
Dose Escalation
Experimental
monotherapy and combination therapy
干预措施: Nivolumab (Biological)
结局指标
主要结局
Incidence of Laboratory Abnormalities
时间窗: 15 months
Safety and Tolerability
AEs leading to discontinuation
时间窗: Up to one year
Safety and Tolerability
Incidence of Serious Adverse Events (SAEs)
时间窗: 15 months
Safety and Tolerability
Incidence of Adverse Events (AEs)
时间窗: 15 months
Safety and Tolerability
Incidence of Death
时间窗: 15 months
Safety and Tolerability
次要结局
- Apparent volume of distribution at steady-state (Vss/F)(Up to one year)
- Best Overall Response (BOR)(Up to one year)
- Time of maximum observed plasma concentration (Tmax)(Up to one year)
- Trough observed plasma concentration at the end of the dosing interval (Ctrough)(Up to one year)
- Percent urinary recovery over 24 hours (%UR24)(Up to 24 hours)
- Biomarker Availability(Up to one year)
- Maximum observed plasma concentration (Cmax)(Up to one year)
- Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)](Up to one year)
- Apparent total body clearance (CLT/F)(Up to one year)
- Incidence of anti-drug antibody (ADA)(Up to one year)
- Duration of Response (DOR)(Up to one year)
研究者
研究点 (1)
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