跳至主要内容
临床试验/NCT06554730
NCT06554730撤回不适用

Non-interventional Post-authorization Study of Belzutifan in Adult Patients With Von Hippel-Lindau Disease-associated Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor and/or Central Nervous System Hemangioblastoma (MK-6482-026)

Merck Sharp & Dohme LLC0 个研究点目标入组 100 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
100
主要终点
Procedure

研究概览

简要总结

This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.

This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number:

EUPAS108114

详细描述

Primary Objective

  • Among new users of belzutifan with VHL disease-associated RCC, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or locally directed therapy (e.g., radiofrequency ablation).
  • Among new users of belzutifan with VHL disease-associated CNS hemangioblastoma, to describe the proportion of patients who undergo at least one CNS tumor reductive surgery (e.g., craniectomy) or locally directed therapy (e.g., radiation therapy).

Secondary Objectives

Among all new users of belzutifan to describe:

  • Proportion of patients with treatment emergent SAEs, including the nature of these events.

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

  • Greater than or equal to 18 years of age
  • Diagnosed with VHL disease based on a germline test or clinical diagnosis
  • A decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label
  • Signed informed consent prior to or withing 30 days after the first inititaion of belzutifan

排除标准

  • Anti-cancer systemic therapy within 2 weeks prior to the index date
  • Unable to consent to participate in the study
  • History of VHL disease-related metastasis or advanced cancer

结局指标

主要结局

Procedure

时间窗: Through study completion

Proportion of patients who undergo surgery or other tumor reductive procedure.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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