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
Sites (84)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Melbourne Hospital ( Site 1602) Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Prince of Wales Hospital-Medical Oncology ( Site 1601) Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203) Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Princess Margaret Cancer Centre ( Site 0202) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Fundación Arturo López Pérez ( Site 2200) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Centro de Oncología de Precisión ( Site 2203) Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Peking University First Hospital-Urology ( Site 1900) Coordinator of this site? Confirm its status | Beijing | China | Active, not recruiting |
| West China Hospital of Sichuan University ( Site 1906) Coordinator of this site? Confirm its status | Chengdu | China | Completed |
| Sun Yat-sen University Cancer Center ( Site 1905) Coordinator of this site? Confirm its status | Guangzhou | China | Active, not recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904) Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503) Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505) Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Universitaetsklinikum Freiburg ( Site 0504) Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501) Coordinator of this site? Confirm its status | München | Germany | Completed |
| Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500) Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Rigshospitalet-Department of Endocrinology ( Site 0303) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Active, not recruiting |
| Rigshospitalet ( Site 0304) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Active, not recruiting |
| Odense Universitetshospital ( Site 0302) Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron ( Site 1100) Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103) Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center-Oncology ( Site 1102) Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101) Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407) Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Hôpital Edouard Herriot-oncologie ( Site 0405) Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes-Oncology ( Site 0406) Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404) Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402) Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Gustave Roussy ( Site 0403) Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Addenbrooke's Hospital ( Site 1309) Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| The Beatson West of Scotland Cancer Centre ( Site 1308) Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Hammersmith Hospital-Medical Oncology ( Site 1304) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Free Hospital ( Site 1302) Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600) Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 1401) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708) Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701) Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele-Oncologia Medica ( Site 0705) Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704) Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706) Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona ( Site 0703) Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| National Cancer Center Hospital ( Site 1802) Coordinator of this site? Confirm its status | Chuo-ku | Japan | Active, not recruiting |
| Kyoto University Hospital ( Site 1806) Coordinator of this site? Confirm its status | Kyoto | Japan | Active, not recruiting |
| Kochi Medical School Hospital ( Site 1807) Coordinator of this site? Confirm its status | Nankoku | Japan | Active, not recruiting |
| Hokkaido University Hospital ( Site 1800) Coordinator of this site? Confirm its status | Sapporo | Japan | Active, not recruiting |
| Tokyo Women's Medical University Adachi Medical Center ( Site 1803) Coordinator of this site? Confirm its status | Tokyo | Japan | Active, not recruiting |
| Yokohama City University Hospital ( Site 1804) Coordinator of this site? Confirm its status | Yokohama | Japan | Active, not recruiting |
| Seoul National University Hospital ( Site 2001) Coordinator of this site? Confirm its status | Jongno-gu | South Korea | Completed |
| Asan Medical Center ( Site 2000) Coordinator of this site? Confirm its status | Songpa-gu | South Korea | Active, not recruiting |
| Universitair Medisch Centrum Utrecht ( Site 1530) Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Oslo Universitetssykehus Radiumhospitalet ( Site 2400) Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| START Lisbon - Hospital de Santa Maria ( Site 2601) Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600) Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809) Coordinator of this site? Confirm its status | Moscow | Russia | Completed |
| Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801) Coordinator of this site? Confirm its status | Moscow | Russia | Active, 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 Petersburg | Russia | Completed |
| Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Active, not recruiting |
| GBUZ Republican Clinical Oncological Dispensary ( Site 0804) Coordinator of this site? Confirm its status | Ufa | Russia | Completed |
| Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204) Coordinator of this site? Confirm its status | Gothenburg | Sweden | Active, not recruiting |
| Skanes University Hospital Lund ( Site 1200) Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| Karolinska Universitetssjukhuset Solna ( Site 1202) Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201) Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
| National Cancer Centre Singapore ( Site 1700) Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| University of Michigan ( Site 0126) Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| National Institutes of Health ( Site 0125) Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Massachusetts General Hospital ( Site 0111) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 0112) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa ( Site 0104) Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Cedars-Sinai Medical Center ( Site 0110) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| SCRI Oncology Partners ( Site 7000) Coordinator of this site? Confirm its status | Nashville | United States | Completed |
| Vanderbilt University Medical Center ( Site 0107) Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai ( Site 0123) Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127) Coordinator of this site? Confirm its status | Philadelphia | United States | Active, not recruiting |
| Washington University-Internal Medicine/Oncology ( Site 0124) Coordinator of this site? Confirm its status | St Louis | United States | Active, not recruiting |
| Northwestern Medicine Cancer Center - Warrenville ( Site 0134) Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| Hacettepe Universitesi-oncology hospital ( Site 0901) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent Şehir Hastanesi. ( Site 0904) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ege University Medicine of Faculty ( Site 0900) Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Completed |
| Baskent University Adana Training Hospital ( Site 0906) Coordinator of this site? Confirm its status | Yüreğir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.