6482-026
Research type
Research Study
Full title
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.
IRAS ID
352268
Contact name
Eamonn Maher
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Duration of Study in the UK
5 years, 8 months, 0 days
Research summary
This is a post-authorisation study evaluating the effectiveness and safety of belzutifan in routine clinical practice. It will include Adult (≥18 years of age) patients with von Hippel-Lindau (VHL) disease for which a decision has been made by the treating physician to initiate belzutifan treatment. The study aims to enroll up to 100 patients with VHL disease-associated renal cell carcinoma (RCC) and/or
central nervous system (CNS) hemangioblastoma. This includes approximately 40 patients with VHL disease-associated RCC and approximately 40 patients with VHL disease-associated CNS hemangioblastoma who require treatment per investigator’s judgment for the primary effectiveness analysis.
The planned minimum follow-up for each patient will be 3 years. The planned maximum follow-up will be up to 5-6 years. The study is being sponsored by Merck and is planned to be conducted in the USA (United states), Canada and UK (United Kingdom). Other countries may be added once the drug is approved in those countries.REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0016
Date of REC Opinion
14 Feb 2025
REC opinion
Favourable Opinion