Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorJosé Claudio Casali da Rocha

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Belzutifan

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

José Claudio Casali da Rocha

Lead sponsor

AC Camargo Cancer Center

Sponsor institution

AC Camargo Cancer Center

Collaborator