NCT03029780已完成2 期
Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Bristol-Myers Squibb16 个研究点 分布在 3 个国家目标入组 104 人开始时间: 2017年2月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 16
- 主要终点
- The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Advanced Renal Cell Carcinoma
- •Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- •Must have at least 1 lesion with measurable disease
排除标准
- •Subjects with active central nervous system metastases
- •Subjects who received prior therapy with checkpoint inhibitor
- •Subjects with active, known or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period
时间窗: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).
次要结局
- Progression Free Survival (PFS)(From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months))
- The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination Period(From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months))
- The Percentage of Participants With All Causality Grade 3-5 Adverse Events(From first dose to 30 days after last dose of study therapy (up to approximately 48 months))
- Objective Response Rate (ORR)(From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months))
- Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab(EOI on day 1 of cycle 1, 2, and 4)
- The Percentage of Participants With Drug Related Grade 3-5 Adverse Events(From first dose to 30 days after last dose of study therapy (up to approximately 48 months))
- Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab(pre-dose on day 1 of cycle 2 and 4)
研究者
研究点 (16)
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