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NCT04924075RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
355 (estimated)
First submitted
8 Jun 2021
Start date
12 Aug 2021
Primary completion date
18 Nov 2032
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT04924075
EU CT number
2023-504853-11-00
EudraCT number
2020-005028-13

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 355
  • From 12 Aug 2021 to the primary completion date, 18 Nov 2032
  • 84 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (84)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Royal Melbourne Hospital ( Site 1602)
Coordinator of this site? Confirm its status
ParkvilleAustraliaRecruiting
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Coordinator of this site? Confirm its status
RandwickAustraliaRecruiting
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
Princess Margaret Cancer Centre ( Site 0202)
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Fundación Arturo López Pérez ( Site 2200)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Centro de Oncología de Precisión ( Site 2203)
Coordinator of this site? Confirm its status
SantiagoChileActive, not recruiting
Peking University First Hospital-Urology ( Site 1900)
Coordinator of this site? Confirm its status
BeijingChinaActive, not recruiting
West China Hospital of Sichuan University ( Site 1906)
Coordinator of this site? Confirm its status
ChengduChinaCompleted
Sun Yat-sen University Cancer Center ( Site 1905)
Coordinator of this site? Confirm its status
GuangzhouChinaActive, not recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Coordinator of this site? Confirm its status
ShanghaiChinaActive, not recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Coordinator of this site? Confirm its status
DüsseldorfGermanyRecruiting
Universitaetsklinikum Freiburg ( Site 0504)
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyRecruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
Coordinator of this site? Confirm its status
MünchenGermanyCompleted
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Coordinator of this site? Confirm its status
WürzburgGermanyRecruiting
Rigshospitalet-Department of Endocrinology ( Site 0303)
Coordinator of this site? Confirm its status
CopenhagenDenmarkActive, not recruiting
Rigshospitalet ( Site 0304)
Coordinator of this site? Confirm its status
CopenhagenDenmarkActive, not recruiting
Odense Universitetshospital ( Site 0302)
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Odense CDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron ( Site 1100)
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Coordinator of this site? Confirm its status
MadridSpainRecruiting
MD Anderson Cancer Center-Oncology ( Site 1102)
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Coordinator of this site? Confirm its status
OviedoSpainRecruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceRecruiting
Hôpital Edouard Herriot-oncologie ( Site 0405)
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LyonFranceRecruiting
Institut Paoli-Calmettes-Oncology ( Site 0406)
Coordinator of this site? Confirm its status
MarseilleFranceActive, not recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Gustave Roussy ( Site 0403)
Coordinator of this site? Confirm its status
VillejuifFranceActive, not recruiting
Addenbrooke's Hospital ( Site 1309)
Coordinator of this site? Confirm its status
CambridgeUnited KingdomRecruiting
The Beatson West of Scotland Cancer Centre ( Site 1308)
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
Hammersmith Hospital-Medical Oncology ( Site 1304)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Royal Free Hospital ( Site 1302)
Coordinator of this site? Confirm its status
LondonUnited KingdomActive, not recruiting
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Sourasky Medical Center ( Site 1401)
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Coordinator of this site? Confirm its status
MilanItalyCompleted
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Coordinator of this site? Confirm its status
NaplesItalyCompleted
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Coordinator of this site? Confirm its status
SienaItalyRecruiting
Centro Ricerche Cliniche di Verona ( Site 0703)
Coordinator of this site? Confirm its status
VeronaItalyRecruiting
National Cancer Center Hospital ( Site 1802)
Coordinator of this site? Confirm its status
Chuo-kuJapanActive, not recruiting
Kyoto University Hospital ( Site 1806)
Coordinator of this site? Confirm its status
KyotoJapanActive, not recruiting
Kochi Medical School Hospital ( Site 1807)
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NankokuJapanActive, not recruiting
Hokkaido University Hospital ( Site 1800)
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SapporoJapanActive, not recruiting
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Coordinator of this site? Confirm its status
TokyoJapanActive, not recruiting
Yokohama City University Hospital ( Site 1804)
Coordinator of this site? Confirm its status
YokohamaJapanActive, not recruiting
Seoul National University Hospital ( Site 2001)
Coordinator of this site? Confirm its status
Jongno-guSouth KoreaCompleted
Asan Medical Center ( Site 2000)
Coordinator of this site? Confirm its status
Songpa-guSouth KoreaActive, not recruiting
Universitair Medisch Centrum Utrecht ( Site 1530)
Coordinator of this site? Confirm its status
UtrechtNetherlandsRecruiting
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Coordinator of this site? Confirm its status
OsloNorwayActive, not recruiting
START Lisbon - Hospital de Santa Maria ( Site 2601)
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Coordinator of this site? Confirm its status
MoscowRussiaCompleted
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Coordinator of this site? Confirm its status
MoscowRussiaActive, not recruiting
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
Coordinator of this site? Confirm its status
Saint PetersburgRussiaCompleted
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Coordinator of this site? Confirm its status
Saint PetersburgRussiaActive, not recruiting
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Coordinator of this site? Confirm its status
UfaRussiaCompleted
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Coordinator of this site? Confirm its status
GothenburgSwedenActive, not recruiting
Skanes University Hospital Lund ( Site 1200)
Coordinator of this site? Confirm its status
LundSwedenActive, not recruiting
Karolinska Universitetssjukhuset Solna ( Site 1202)
Coordinator of this site? Confirm its status
StockholmSwedenCompleted
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Coordinator of this site? Confirm its status
UppsalaSwedenActive, not recruiting
National Cancer Centre Singapore ( Site 1700)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
University of Michigan ( Site 0126)
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
National Institutes of Health ( Site 0125)
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
Massachusetts General Hospital ( Site 0111)
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Texas MD Anderson Cancer Center ( Site 0112)
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HoustonUnited StatesRecruiting
University of Iowa ( Site 0104)
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
Cedars-Sinai Medical Center ( Site 0110)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
SCRI Oncology Partners ( Site 7000)
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NashvilleUnited StatesCompleted
Vanderbilt University Medical Center ( Site 0107)
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NashvilleUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai ( Site 0123)
Coordinator of this site? Confirm its status
New YorkUnited StatesActive, not recruiting
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesActive, not recruiting
Washington University-Internal Medicine/Oncology ( Site 0124)
Coordinator of this site? Confirm its status
St LouisUnited StatesActive, not recruiting
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Coordinator of this site? Confirm its status
WarrenvilleUnited StatesRecruiting
Hacettepe Universitesi-oncology hospital ( Site 0901)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ege University Medicine of Faculty ( Site 0900)
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BornovaTurkey (Türkiye)Recruiting
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
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IstanbulTurkey (Türkiye)Completed
Baskent University Adana Training Hospital ( Site 0906)
Coordinator of this site? Confirm its status
YüreğirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.