2024-512016-22-00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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Incyte Corp.
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
研究概览
简要总结
To estimate the objective response rate (ORR) as measured per RECIST 1.1 by investigator determination of pembrolizumab plus epacadostat and SoC (sunitinib or pazopanib)
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
- 否
入选标准
- •Histologic confirmation of locally advanced or metastatic renal cell carcinoma (mRCC) 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 Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
- •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.
结局指标
主要结局
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
次要结局
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
研究者
Lulama Rhoda Molife
Scientific
Incyte Corp.
研究点 (1)
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