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Looking for participantsPhase2

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT04924075

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Belzutifan (drug)
How long the study runs
Study runs about 135 months (dates as stated)
About the drug or intervention
Belzutifan — drug: Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
355
Started
2021-08-12
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for pheochromocytoma/paraganglioma
  • • Phase2 - 355 participants
  • • This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with pheochromocytoma/paraganglioma

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 1309)
  • • London - Royal Free Hospital ( Site 1302)
  • • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 1308)
  • • London - Hammersmith Hospital-Medical Oncology ( Site 1304)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Pheochromocytoma/ParagangliomaPancreatic Neuroendocrine TumorVon Hippel-Lindau DiseaseAdvanced Gastrointestinal Stromal TumorHIF-2α Mutated Cancers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

advanced wild-type

Treatment history

Treatments you must have had:

  • ✓ intermittent supplemental oxygen, or requires chronic supplemental oxygen
  • ✓ (except somatostatin analogs) with chemotherapy

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
  • ✓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
See the full criteria
The main inclusion criteria include but are not limited to the following: * 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 The main exclusion criteria include but are not limited to the following: * 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

Where Is This Study? (4 UK sites)

Addenbrooke's Hospital ( Site 1309)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223245151

Royal Free Hospital ( Site 1302)

London NW3 2QG, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

The Beatson West of Scotland Cancer Centre ( Site 1308)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 141 301 7055

Hammersmith Hospital-Medical Oncology ( Site 1304)

London W12 OHS, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0208 383 3089

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10