NCT03873402进行中（未招募）3 期
A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors
Bristol-Myers Squibb78 个研究点 分布在 9 个国家目标入组 437 人开始时间: 2019年6月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 437
- 试验地点
- 78
- 主要终点
- Objective response rate (ORR) by BICR
研究概览
简要总结
The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
- •Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
- •No prior systemic therapy for RCC
- •Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
排除标准
- •Any active central nervous system (CNS) metastases.
- •Active, known, or suspected autoimmune disease.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab + ipilimumab
Experimental
干预措施: Nivolumab (Biological)
Nivolumab + ipilimumab
Experimental
干预措施: Ipilimumab (Biological)
Nivolumab + ipilimumab placebo
Experimental
干预措施: Ipilimumab placebo (Other)
结局指标
主要结局
Objective response rate (ORR) by BICR
时间窗: Up to 23 months
Progression free survival (PFS) by blinded independent central review (BICR)
时间窗: Up to 34 months
次要结局
- Overall survival (OS)(Up to 4 years)
- Progression Free Survival (PFS) by investigator(Up to 4 years)
- Duration of response (DoR) by BICR(Up to 4 years)
- Incidence of clinically significant changes in clinical laboratory results: Coagulation tests(Up to 4 years)
- Objective response rate (ORR) based on GEP signatures(Up to 4 years)
- PFS by BICR based on PD-L1 expression(Up to 4 years)
- Overall response rate (ORR) by investigator(Up to 4 years)
- Incidence of drug-related AEs(Up to 4 years)
- Incidence of clinically significant changes in clinical laboratory results: Serology tests(Up to 4 years)
- OS based on GEP signatures(Up to 4 years)
- OS based on programmed cell death protein ligand-1 (PD-L1) expression(Up to 4 years)
- ORR by BICR based on PD-L1 expression(Up to 4 years)
- Disease control rate (DCR) by investigator(Up to 4 years)
- Progression free survival secondary objective (PFS2) by investigator(Up to 4 years)
- Disease control rate (DCR) by BICR(Up to 4 years)
- Incidence of drug-related SAEs(Up to 4 years)
- PFS based on gene expression (GEP) signatures(Up to 4 years)
- Time to objective response (TTR) by investigator(Up to 4 years)
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to 4 years)
- Duration of response (DoR) by investigator(Up to 4 years)
- Time to objective response (TTR) by BICR(Up to 4 years)
- Incidence of Adverse Events (AEs)(Up to 4 years)
- Incidence of Severe Adverse Events (SAEs)(Up to 4 years)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 4 years)
研究者
研究点 (78)
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