NCT07167329RecruitingPhase 2
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
The BELIEVE-VHL Trial: A Real-world Longitudinal Study on Belzutifan's Effectiveness, Pharmacogenetics, and Pharmacoeconomics in Von Hippel-Lindau (VHL) Syndrome Using the HIF2α Inhibitor Belzutifan
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Jan 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- José Claudio Casali da Rocha
- Diseases
- Kidney cancer, Childhood cancers
- NCT number
- NCT07167329
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Jan 2024 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.
- 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.
Age
- Age \< 14 years.
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AC Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.