NCT06554730WithdrawnNot Applicable
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)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 100
- Primary Endpoint
- Procedure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Procedure
Time Frame: Through study completion
Proportion of patients who undergo surgery or other tumor reductive procedure.
Secondary Outcomes
No secondary outcomes reported
Investigators
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