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临床试验/NCT04957160
NCT04957160已完成不适用

A Multicentre, Retrospective, Non-interventional Review of Electronic Prescribing Records of Any Second-line (2L) Patients and Chart Notes of 2L Cabozantinib Patients, Investigating the Treatment Sequence Pathway Following a First-line, Immuno-oncology Checkpoint Inhibitor (1L IO) Containing Combination Therapy in Patients With Advanced Renal Cell Carcinoma (aRCC) (CARINA)

Ipsen9 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2021年9月9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
281
试验地点
9
主要终点
Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC

研究概览

简要总结

This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients with a diagnosis of aRCC.
  • Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment.

排除标准

  • Patient's hospital medical records are unavailable for review;
  • Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).

结局指标

主要结局

Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC

时间窗: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy.

Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC

时间窗: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy.

次要结局

  • Overall Response Rate (ORR) by line -complete response or partial response(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Duration of treatment by line(From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022))
  • Progression Free Survival (PFS) by line for cabozantinib patients(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Overall Survival (OS)(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Drug start and end dose by line(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Disease Control Rate (DCR) by line - complete response, partial response and stable disease(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Time to Treatment Discontinuation (TTD) by line(From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022))
  • Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Reason for stopping cabozantinib(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Describe interruptions for cabozantinib(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Reason for dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other)(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))
  • Cause of death (RCC or non RCC related)(From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022))

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (9)

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