Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects. It furthermore holds microbiome characterization of CPI-treated patients.
Furthermore, the investigators examines the role of anti-drug antibodies and receptor polymorphisms in CTLA-4 and PD-1 receptors in treatment failure among patients with mRCC treated with check point immunotherapy (CPI). Moreover, polymorphisms in the UGT1A1 gene will be correlated with the pazopanib treatment dose.
详细描述
BACKGROUND:
Treatment of metastatic renal cell carcinoma (mRCC) is ineffective among 25 % of patients. However, treatment still reduces patients' quality of life.
From clinical experience, interindividual dose requirements vary greatly among patients with mRCC treated with tyrosine kinase inhibitors.
The investigators expect this to partly be explained by great variation in the plasma concentration of treatment drugs. Furthermore, treatment failure among patients with mRCC treated with check point immunotherapy has not been fully investigated.
RATIONALE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients in Denmark with medically treated metastatic renal cell carcinoma.
排除标准
- •No written informed consent.
研究组 & 干预措施
Cohort 1
Patients treated for metastatic renal cell carcinoma in Denmark over a 6-year period.
干预措施: Measurement of concentration of active metabolite in cancer treatment. (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: 12 months follow-up for each patient.
Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.
Progression free survival (PFS)
时间窗: 12 months follow-up for each patient.
According to the RECIST v1.1
Quality of life according to NCCN-FACT FKSI-19.
时间窗: 12 months follow-up for each patient.
National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19). 19 items, each item scored on a 5 point Likert-scale, covering cancer quality of life.
次要结局
- Amount of antidrug antibodies (ADAs) developed.(12 months follow-up for each patient.)
- SNP-genotype of PD-1 and CTLA-4 receptors reported as proportion of patients with pp-, pq- and qq-genotype respectively.(12 months follow-up for each patient.)
- In pts treated with pazopanib: UGT1A1 genetic polymorphism(At baseline)
- Fecal swap(12 months follow-up for each patient)
- Measuring CT DNA in patiets receiving nivolumab and ipilimumab(12 months follow-up for each patient)
研究者
Niels Fristrup
MD PhD
Aarhus University Hospital