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)
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
- Pheochromocytoma/Paraganglioma
- Pancreatic Neuroendocrine Tumor
- Von Hippel-Lindau Disease
- Advanced Gastrointestinal Stromal Tumor
- HIF-2α Mutated Cancers
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 355
- Started
- 12 August 2021
- Main results due
- 18 November 2032
- Study sites
- 84
- Registry updated
- 25 September 2026
Can you take part?
- Aged 12 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(84)
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California, United States
Recruiting
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago, Illinois, United States
Recruiting
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Warrenville, Illinois, United States
Recruiting
University of Iowa ( Site 0104)
Iowa City, Iowa, United States
Recruiting
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Baltimore, Maryland, United States
Recruiting
National Institutes of Health ( Site 0125)
Bethesda, Maryland, United States
Recruiting
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts, United States
Recruiting
University of Michigan ( Site 0126)
Ann Arbor, Michigan, United States
Recruiting
Washington University-Internal Medicine/Oncology ( Site 0124)
St Louis, Missouri, United States
Active, not recruiting
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York, United States
Active, not recruiting
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania, United States
Active, not recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Completed
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee, United States
Recruiting
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas, United States
Recruiting
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick, New South Wales, Australia
Recruiting
The Royal Melbourne Hospital ( Site 1602)
Parkville, Victoria, Australia
Recruiting
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary, Alberta, Canada
Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
Recruiting
FALP ( Site 2200)
Santiago, Region M. de Santiago, Chile
Recruiting
Centro de Oncología de Precisión ( Site 2203)
Santiago, Region M. de Santiago, Chile
Recruiting
Peking University First Hospital-Urology ( Site 1900)
Beijing, Beijing Municipality, China
Active, not recruiting
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou, Guangdong, China
Active, not recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai, Shanghai Municipality, China
Active, not recruiting
West China Hospital of Sichuan University ( Site 1906)
Chengdu, Sichuan, China
Completed
Rigshospitalet ( Site 0304)
Copenhagen, Capital Region, Denmark
Active, not recruiting
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen, Capital Region, Denmark
Active, not recruiting
Odense Universitetshospital ( Site 0302)
Odense C, Region Syddanmark, Denmark
Active, not recruiting
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg, Alsace, France
Recruiting
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon, Auvergne-Rhône-Alpes, France
Recruiting
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille, Bouches-du-Rhone, France
Active, not recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre, Paris, France
Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris, France
Recruiting
Gustave Roussy ( Site 0403)
Villejuif, Île-de-France Region, France
Active, not recruiting
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
München, Bavaria, Germany
Completed
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg, Bavaria, Germany
Recruiting
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf, North Rhine-Westphalia, Germany
Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Berlin, Germany
Recruiting
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest, Hungary
Recruiting
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan, Israel
Recruiting
Sourasky Medical Center ( Site 1401)
Tel Aviv, Israel
Recruiting
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples, Campania, Italy
Completed
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Milan, Lombardy, Italy
Recruiting
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Siena, Tuscany, Italy
Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna, Italy
Recruiting
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia, Italy
Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milan, Italy
Completed
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Milan, Italy
Recruiting
Centro Ricerche Cliniche di Verona ( Site 0703)
Verona, Italy
Recruiting
Hokkaido University Hospital ( Site 1800)
Sapporo, Hokkaido, Japan
Active, not recruiting
Yokohama City University Hospital ( Site 1804)
Yokohama, Kanagawa, Japan
Active, not recruiting
Kochi Medical School Hospital ( Site 1807)
Nankoku, Kochi, Japan
Active, not recruiting
National Cancer Center Hospital ( Site 1802)
Chuo-ku, Tokyo, Japan
Recruiting
Kyoto University Hospital ( Site 1806)
Kyoto, Japan
Active, not recruiting
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo, Japan
Active, not recruiting
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht, Netherlands
Recruiting
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo, Norway
Active, not recruiting
START Lisbon - Hospital de Santa Maria ( Site 2601)
Lisbon, Lisbon District, Portugal
Recruiting
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Porto, Portugal
Recruiting
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa, Baskortostan, Respublika, Russia
Completed
Showing 60 of 84 sites — filter to narrow it down. 49 of the 84 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04924075. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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