NCT07167329 Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
| NCT ID | NCT07167329 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | José Claudio Casali da Rocha |
| Condition | Von Hippel Lindau |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-01-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 disease progression in patients with von Hippel-Lindau (VHL) syndrome.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
José Claudio Casali da Rocha, Head of Oncogenetics
✉ casali.rocha@accamargo.org.br📞 +55 41 98505 8585
Frequently Asked Questions
Who can join the NCT07167329 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Von Hippel Lindau. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07167329 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07167329 currently recruiting?
Yes, NCT07167329 is actively recruiting participants. Contact the research team at casali.rocha@accamargo.org.br for enrollment information.
Where is the NCT07167329 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07167329 clinical trial?
NCT07167329 is sponsored by José Claudio Casali da Rocha. The trial plans to enroll 100 participants.