NCT03260894已完成3 期
A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 279
- 主要终点
- Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.
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
- •Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
- •Must not have received any prior systemic therapy for their mRCC.
- •Measurable disease based on RECIST v1.
- •Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
- •Karnofsky performance status ≥ 70%.
- •Adequate organ function per protocol-defined criteria.
排除标准
- •Use of protocol-defined prior/concomitant therapy.
- •Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
- •History of severe hypersensitivity reaction to study treatments or their excipients.
- •Active autoimmune disease that has required systemic treatment in past 2 years.
- •Known additional malignancy that has progressed or has required active treatment in the last 3 years.
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
- •History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- •Significant cardiac event within 12 months before Cycle 1 Day 1.
研究组 & 干预措施
Pembrolizumab + Epacadostat
Experimental
干预措施: Pembrolizumab (Drug)
SoC (Sunitinib or Pazopanib)
Active Comparator
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
干预措施: Sunitinib (Drug)
Pembrolizumab + Epacadostat
Experimental
干预措施: Epacadostat (Drug)
SoC (Sunitinib or Pazopanib)
Active Comparator
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
干预措施: Pazopanib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
时间窗: Minimum up to 6 months
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
次要结局
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)(Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.)
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs(Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.)
研究者
研究点 (279)
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