2023-508264-29-00招募中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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 43
- 主要终点
- Progression free survival (PFS) by BICR
研究概览
简要总结
- To compare the PFS using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
- To compare the ORR using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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 CT or MRI per 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
结局指标
主要结局
Progression free survival (PFS) by BICR
Progression free survival (PFS) by BICR
Overall Response Rate (ORR) by BICR
Overall Response Rate (ORR) by BICR
次要结局
- Overall survival (OS)
- Overall response rate (ORR) by Investigator
- Disease control rate (DCR) by Investigator and by blinded independent central review (BICR)
- Duration of response (DoR) by Investigator and by blinded independent central review (BICR)
- Time to objective response (TTR) by Investigator and by blinded independent central review (BICR)
- Progression free survival (PFS) and PFS2 per Investigator
- Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests)
- PFS, ORR and OS based on GEP signatures
- Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression
- Overall response rate (ORR) by BICR based on PD-L1 expression
- Progression Free Survival (PFS) by BICR based on PD-L1 expression)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (43)
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