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Taking peoplePhase 2

Tests belzutifan in advanced tumors linked to HIF-2α gene changes

Tests belzutifan in people with advanced pheochromocytoma or pancreatic neuroendocrine tumors.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Moscow, Saint Petersburg, and Ufa, RussiaSee the 5 sitesAlso in 21 other countries, 81 sites
Registry title
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)
Status
Recruiting
Phase
Phase 2
People taking part
355 people, planned
Started
12 Aug 2021
Expected to end
18 Nov 2032
Type of study
Interventional
Treatments tested
  • Belzutifan
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 12 or older with advanced pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumor, von Hippel-Lindau disease tumors, advanced wild-type GIST, or advanced solid tumors with HIF-2α related gene changes.

Age
At least 12 years; at least 18 years for the von Hippel-Lindau group (Cohort B1).
Sex
All sexes can join.
Disease stage
Advanced or metastatic pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumor, advanced wild-type GIST, or advanced solid tumors with HIF-2α related genetic alterations. Von Hippel-Lindau disease with localized tumors.
Earlier treatment
People who had chemotherapy, targeted therapy, biologics, or other investigational therapy within 4 weeks of the first dose cannot join. Somatostatin analogs are allowed.
Biomarker or test result
Advanced solid tumors need HIF-2α related genetic alterations. The von Hippel-Lindau group needs a diagnosis by a germline (inherited) gene test and/or clinical diagnosis.

Main reasons for not taking part

  • Cannot swallow medicine or has a disorder that affects absorption of belzutifan
  • Second cancer, unless treatment was completed with no sign of cancer for 2 years
  • Pulse oximeter reading below 92% at rest, or needs extra oxygen
  • Serious heart disease, such as unstable angina, recent heart attack or bypass, or heart failure Class III or IV
  • Life expectancy under 3 months

The registry criteria, word for word

Show all 10 criteriaShow less

Other 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old is the patient who may join a trial?
  • Apart from your pancreatic cancer, have you had another cancer in the last 3 years?

Where in Russia

Also in 21 other countries, 81 sites

  • Endocrinology Research Center of Rosmedtechnologies-Surgery (Site 0809)Moscow, RussiaContact: Toll Free NumberNo longer taking part
  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF (Site 0801)Moscow, RussiaContact: Toll Free NumberNo longer taking part
  • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (Site 0805)Saint Petersburg, RussiaContact: Toll Free NumberNo longer taking part
  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy (Site 0803)Saint Petersburg, RussiaContact: Toll Free NumberNo longer taking part
  • GBUZ Republican Clinical Oncological Dispensary (Site 0804)Ufa, RussiaContact: Toll Free NumberNo longer taking part

About the trial

What the trial wants to find out

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).

The group in the trial

  • BelzutifanTreatment being tested

    Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations
Plain-language title
Tests belzutifan in advanced tumors linked to HIF-2α gene changesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04924075, who can take part
Record updated
13 November 2026