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Trial Title:
Merck Belzutifan PAS
NCT ID:
NCT06554730
Condition:
Von Hippel Lindau Disease
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Von Hippel-Lindau Disease
Belzutifan
Conditions: Keywords:
Belzutifan
VHL
RCC
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Merck Belzutifan PAS in adult patients
Description:
There is no intervention for this study. This study will be collecting data from the EMR
of consenting subjects who are taking Belzutifan.
Summary:
This is a prospective observational cohort study evaluating the effectiveness and safety
of belzutifan treatment in routine clinical practice.
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 ยน, 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
Criteria for eligibility:
Study pop:
MD Anderson Cancer Center
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Priyanka Iyer, MBBS
Phone:
832-291-6069
Email:
piyer@mdanderson.org
Investigator:
Last name:
Priyanka Iyer, MBBS
Email:
Principal Investigator
Start date:
January 31, 2025
Completion date:
May 13, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06554730
http://www.mdanderson.org
