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Belzutifan for Advanced Cancers

This study is testing a drug called belzutifan (120 mg, taken by mouth once daily) for people with certain advanced cancers. These include pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), tumors related to Von Hippel-Lindau (VHL) disease, advanced gastrointestinal stromal tumor (wt GIST), or other solid tumors with specific genetic changes related to HIF-2α. The main goal is to see how many participants experience a reduction in their tumor size or a complete disappearance of the tumor. You may be able to join if you are at least 12 years old and have one of these diagnoses. The study plans to enroll 355 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to evaluate the effectiveness and safety of belzutifan in approximately 355 participants.
What's involved
You would take belzutifan orally once daily until your disease progresses or you need to stop treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how your tumors respond for up to approximately 5.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04924075

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Recruiting
PHASE2Ages 12+InterventionalTreatment
Merck Sharp & Dohme LLC
~355 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Belzutifan

At a glance

Recruiting sites
56 of 84 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 5.5 years

Conditions

Pheochromocytoma/Paraganglioma
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor
HIF-2α Mutated Cancers

Explore related trials

Adrenal Gland PheochromocytomaGastrointestinal Stromal TumorPancreatic Neuroendocrine TumorParagangliomaSolid NeoplasmVon Hippel Lindau SyndromeHIF-2αVon Hippel-Lindau Disease Tumor Suppressor

NCT04924075

Where you'd take part

This study runs at 84 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Addenbrooke's Hospital ( Site 1309)

    Cambridge, Cambridgeshire, United Kingdomstudy coordinator listed

    Recruiting

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)

    Uppsala, Uppsala County, Swedenstudy coordinator listed

    Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 0904)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)

    Calgary, Alberta, Canadastudy coordinator listed

    Recruiting

  • Asan Medical Center ( Site 2000)

    Songpa-gu, Seoul, South Koreastudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)

    Brescia, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)

    Siena, Tuscany, Italystudy coordinator listed

    Recruiting

  • Baskent University Adana Training Hospital ( Site 0906)

    Yüreğir, Adana, Turkey (Türkiye)study coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations
Cohort B1: VHL Disease-associated tumors:
Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis
Must be ≥18 years of age
Has a life expectancy of at least 3 months

Exclusion

Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Any of the following: A pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure
Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention

What this trial measures

  • Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)Up to approximately 5.5 years

    ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due to any cause, whichever occurs first.