CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).
详细描述
One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.
Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.
Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).
Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.
Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Renal cell carcinoma patient: histological confirmed clear cell tumor;
- •First-line metastatic treatment;
- •Stage IV with at least one measured lesion;
- •Fresh-frozen primary tumor tissue available;
- •No previous immunotherapy or tyrosine kinase inhibitor treatment;
- •All International Metastatic RCC Database Consortium (IMDC) Risk Score;
- •Karnofsky Performance Scale (KPS) >=70;
- •>=18 years old.
排除标准
- •History of a known or suspected autoimmune disease;
- •Any condition requiring systemic treatment with corticosteroids;
- •Creatinine clearance < 40mL/min;
- •Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) > 5 x ULN;
- •Pregnant women.
研究组 & 干预措施
Nivolumab+Ipilimumab
Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.
干预措施: Nivolumab (Drug)
Nivolumab+Ipilimumab
Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 years
Progression-free survival
时间窗: 2 years
次要结局
- Overall Response Rate(2 years)
研究者
Leandro M Colli, MD PhD
Head of Oncology
Hospital das Clínicas de Ribeirão Preto