Actively Recruiting

Phase 2
Age: 14Years +
All Genders
NCT07167329

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

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

AC Camargo Cancer Center

São Paulo, São Paulo, Brazil, 01509900

Actively Recruiting

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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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