Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Genomic profiling
研究概览
简要总结
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
详细描述
The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.
The study plan to enroll about 80 patients in 10 Italian centers:
Group A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)
Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).
Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of >500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years.
- •Patients with histological diagnosis of predominantly clear cell carcinoma
- •Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
- •Evaluable disease according to RECIST criteria v 1.1
- •Treatment with cabozantinib after one or more previous therapies for mRCC
- •Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months
- •Any prognosis group according to the IMDC risk score
- •Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.
排除标准
- •Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
- •Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
- •Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
研究组 & 干预措施
Group A: long-lasting responders
Patient long-lasting responders (PFS ≥9 months) to cabozantinib
干预措施: Cabozantinib (Drug)
Group B: primary refractories
Patient progressed from the start to cabozantinib therapy within 3 months
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Genomic profiling
时间窗: 12 months
to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)
次要结局
- Overall response rate (ORR)(12 months)
- Overall Survival (OS)(12 months)
- Duration of response (DOR)(12 months)