Status:
RECRUITING
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
Lead Sponsor:
José Claudio Casali da Rocha
Collaborating Sponsors:
AC Camargo Cancer Center
Conditions:
Von Hippel Lindau
Von Hippel Lindau Disease
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief Summary
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 diseas...
Detailed Description
PRIMARY OBJECTIVE: To evaluate the therapeutic effects, benefits, and adverse effects associated with belzutifan treatment, as well as the timing of treatment response and/or disease progression. SE...
Eligibility Criteria
Inclusion
- Age ≥ 14 years.
- 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 criteria.
- ECOG performance status of 0-2.
- Adequate bone marrow, hepatic, and renal function as defined by laboratory reference values.
- Ability to swallow oral medication.
- Provision of written informed consent prior to enrollment.
Exclusion
- Age \< 14 years.
- Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.
- Presence of an active malignancy outside the VHL tumor spectrum within the past 3 years, except for adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies considered cured for \>2 years.
- Known hypersensitivity or allergic reaction to belzutifan or any excipient in the formulation.
- History of severe or uncontrolled cardiovascular disease, including but not limited to unstable angina, myocardial infarction within the past 6 months, congestive heart failure requiring treatment, or uncontrolled hypertension.
- Active infectious diseases, including HIV, hepatitis B, or hepatitis C.
- Immunosuppressed status, whether due to underlying disease or ongoing therapy.
- History of significant bleeding disorders, including bleeding diathesis, thrombocytopenia, or coagulopathy.
- Radiotherapy administered within 4 weeks prior to study enrollment.
- Major surgical procedure, including for VHL-related tumors, within 4 weeks prior to study enrollment, or immediate need for surgical intervention for tumor management.
- Malabsorption secondary to prior gastrointestinal surgery or active gastrointestinal disease.
- Current use of concomitant medications known to interact with belzutifan and significantly alter its bioavailability.
- Anticipated low adherence to or planned interruption of belzutifan therapy.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07167329
Start Date
January 1 2024
End Date
January 1 2030
Last Update
September 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509900