Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-06-30
2030-12-31
Brief Summary
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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
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* 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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Belzutifan
There is no intervention for this study. This study will be collecting data from the EMR of consenting subjects who are taking Belzutifan.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to consent to participate in the study
* History of VHL disease-related metastasis or advanced cancer
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Related Links
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HMA-EMA Catalogues of real-world data: EU PAS number: EUPAS108114
Other Identifiers
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MK-6482-026
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-06807
Identifier Type: REGISTRY
Identifier Source: secondary_id
EUPAS108114
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-0221
Identifier Type: -
Identifier Source: org_study_id