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临床试验/NCT05361434
NCT05361434已完成不适用

A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults

Ipsen133 个研究点 分布在 7 个国家目标入组 311 人开始时间: 2022年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Ipsen
入组人数
311
试验地点
133
主要终点
Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.

研究概览

简要总结

The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

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

入选标准

  • Participants with diagnosis of aRCC with clear-cell component
  • Participants with no prior systemic treatment for aRCC with clear-cell component;
  • Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;

排除标准

  • Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;
  • History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

结局指标

主要结局

Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.

时间窗: At 18 months follow up

次要结局

  • Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.)
  • Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).(Up to 42 months or disease progression)
  • Change in pain(Change from baseline at each visit up to 42 months)
  • Duration of response (DOR)(Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression)
  • Time of response (TTR)(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression)
  • Pattern of use of nivolumab under real-world practice conditions.(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression)
  • Tumor median progression-free survival (PFS) time(Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression)
  • Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))(Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression)
  • Pattern of use of cabozantinib under real-world practice conditions.(Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression)
  • Change in disease-related symptoms(Change from baseline at each visit up to 42 months)
  • Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation(Up to 42 months.)

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (133)

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