Actively Recruiting
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
Led by José Claudio Casali da Rocha · Updated on 2025-09-11
100
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
J
José Claudio Casali da Rocha
Lead Sponsor
A
AC Camargo Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The BELIEVE-VHL Trial is a prospective real-life study designed to evaluate the therapeutic effects, benefits, and adverse effects of belzutifan, as well as the timing of treatment response and disease progression in patients with von Hippel-Lindau (VHL) syndrome.
CONDITIONS
Official Title
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Clinical or genetic confirmation of von Hippel-Lindau (VHL) syndrome
- Presence of measurable or progressive VHL-associated tumors as defined by RECIST 1.1 or disease-specific imaging
- ECOG performance status between 0 and 2
- Adequate bone marrow, liver, and kidney function based on lab tests
- Ability to swallow oral medication
- Signed informed consent before joining the study
You will not qualify if you...
- Under 14 years of age
- No confirmed diagnosis of von Hippel-Lindau (VHL) syndrome
- Active cancer outside the VHL tumor spectrum within the past 3 years, except certain treated skin or cervical cancers
- Known allergy to belzutifan or any ingredients in its formulation
- History of severe or uncontrolled heart disease, including recent heart attack or unstable angina
- Active infections such as HIV, hepatitis B or C
- Immunosuppressed condition from disease or treatment
- History of serious bleeding disorders
- Radiotherapy within 4 weeks before joining the study
- Major surgery within 4 weeks before joining or need for urgent surgery related to tumors
- Malabsorption due to prior gastrointestinal surgery or active GI disease
- Use of medications that interact strongly with belzutifan
- Expected poor adherence or planned interruption of belzutifan therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509900
Actively Recruiting
Research Team
J
José Claudio Casali da Rocha, Head of Oncogenetics
CONTACT
J
José Reinaldo De Oliveira Junior
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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