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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Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06554730
Enrollment
0
Registered
2024-08-15
Start date
2024-06-30
Completion date
2030-12-31
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Hippel Lindau Disease

Keywords

Belzutifan, VHL

Brief 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

Interventions

OTHERBelzutifan

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

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
ProcedureThrough study completionProportion of patients who undergo surgery or other tumor reductive procedure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026