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MSD Belzutifan PAS


2024-06-30


2030-12-31


2030-12-31


0

Study Overview

MSD Belzutifan PAS

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

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

  • Von Hippel Lindau Disease
  • OTHER: Belzutifan
  • 2023-0221
  • MK-6482-026 (OTHER Identifier) (OTHER: MSD Belzutifan)
  • NCI-2024-06807 (REGISTRY Identifier) (REGISTRY: Clinical Trials Reporting Program)
  • EUPAS108114 (REGISTRY Identifier) (REGISTRY: RWD Catalogues - EU PAS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-08-12  

N/A  

2024-11-26  

2024-08-12  

N/A  

2024-11-29  

2024-08-15  

N/A  

2024-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
ProcedureProportion of patients who undergo surgery or other tumor reductive procedure.Through study completion
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_DIRECTOR: Medical Director, Merck Sharp & Dohme LLC

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available