NCT06554730

MSD Belzutifan PAS

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)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. Treatment patterns including the: * Duration of therapy * Proportion of patients who discontinued treatment, time to treatment discontinuation, and summary of reasons for discontinuation * Proportion of patients who interrupted treatment, time to treatment interruption, duration of treatment interruption, and summary of reasons for treatment interruption * Proportion of patients with dose reductions, and reason for dose reduction. * Among new users of belzutifan with VHL disease-associated RCC and, separately, VHL disease-associated CNS hemangioblastoma, to describe: * Proportion of patients who develop metastatic disease (for RCC only) * Proportion of patients with occurrence of new VHL disease-associated tumor or tumor type

Conditions

• Von Hippel Lindau Disease

Interventions

Type	Name	Description
OTHER	Belzutifan	There is no intervention for this study. This study will be collecting data from the EMR of consenting subjects who are taking Belzutifan.

Timeline

• Start date: 2024-06-30
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2024-08-15
• Last updated: 2024-11-29