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NCT06554730 | NOT YET RECRUITING | Von Hippel Lindau Disease

Merck Belzutifan PAS
Sponsor:

M.D. Anderson Cancer Center

Brief Summary:

This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.

Condition or disease

Von Hippel Lindau Disease

Renal Cell Carcinoma

Intervention/treatment

Merck Belzutifan PAS in adult patients

Detailed Description:

Primary Objective * Among new users ofbelzutifan 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 ofbelzutifan 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 ¹, 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

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : 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.
Actual Study Start Date : 2025-01-31
Estimated Primary Completion Date : 2027-05-13
Estimated Study Completion Date : 2029-05-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Greater than or equal to 18 yeas 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
Merck Belzutifan PAS

Location Details

NCT06554730

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How to Participate

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Locations

Not yet recruiting

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030