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)
NCT ID: NCT04924075
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
322 participants
INTERVENTIONAL
2021-08-12
2029-06-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Interventions
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Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 BI: 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago, Illinois, United States
University of Iowa ( Site 0104)
Iowa City, Iowa, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Baltimore, Maryland, United States
National Institutes of Health ( Site 0125)
Bethesda, Maryland, United States
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts, United States
University of Michigan ( Site 0126)
Ann Arbor, Michigan, United States
Washington University-Internal Medicine/Oncology ( Site 0124)
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York, United States
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas, United States
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick, New South Wales, Australia
The Royal Melbourne Hospital ( Site 1602)
Parkville, Victoria, Australia
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary, Alberta, Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
FALP ( Site 2200)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 2203)
Santiago, Region M. de Santiago, Chile
Peking University First Hospital-Urology ( Site 1900)
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou, Guangdong, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University ( Site 1906)
Chengdu, Sichuan, China
Rigshospitalet ( Site 0304)
Copenhagen, Capital Region, Denmark
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen, Capital Region, Denmark
Odense Universitetshospital ( Site 0302)
Odense C, Region Syddanmark, Denmark
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg, Alsace, France
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon, Auvergne-Rhône-Alpes, France
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille, Bouches-du-Rhone, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre, Paris, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris, , France
Gustave Roussy ( Site 0403)
Villejuif, Île-de-France Region, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
München, Bavaria, Germany
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg, Bavaria, Germany
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg, Brandenburg, Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf, North Rhine-Westphalia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Berlin, , Germany
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest, , Hungary
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 1401)
Tel Aviv, , Israel
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples, Campania, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Siena, Tuscany, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia, , Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milan, , Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Milan, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
Verona, , Italy
Hokkaido University Hospital ( Site 1800)
Sapporo, Hokkaido, Japan
Yokohama City University Hospital ( Site 1804)
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital ( Site 1807)
Nankoku, Kochi, Japan
National Cancer Center Hospital ( Site 1802)
Chuo-ku, Tokyo, Japan
Kyoto University Hospital ( Site 1806)
Kyoto, , Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo, , Japan
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht, , Netherlands
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo, , Norway
START Lisbon - Hospital de Santa Maria ( Site 2601)
Lisbon, Lisbon District, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Porto, , Portugal
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa, Baskortostan, Respublika, Russia
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
Saint Petersburg, Leningradskaya Oblast', Russia
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg, Leningradskaya Oblast', Russia
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow, Moscow, Russia
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow, Moscow, Russia
National Cancer Centre Singapore ( Site 1700)
Singapore, Central Singapore, Singapore
Seoul National University Hospital ( Site 2001)
Jongno-gu, Seoul, South Korea
Asan Medical Center ( Site 2000)
Songpa-gu, Seoul, South Korea
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona, , Spain
Skanes University Hospital Lund ( Site 1200)
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm, Stockholm County, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala, Uppsala County, Sweden
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg, Västra Götaland County, Sweden
Baskent University Adana Training Hospital ( Site 0906)
Yüreğir, Adana, Turkey (Türkiye)
Ege University Medicine of Faculty ( Site 0900)
Bornova, İzmir, Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul, , Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1309)
Cambridge, Cambridgeshire, United Kingdom
Royal Free Hospital ( Site 1302)
London, England, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow, Glasgow City, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 1304)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Jimenez C, Andreassen M, Durand A, Moog S, Hendifar A, Welin S, Spada F, Sharma R, Wolin E, Ruether J, Garcia-Carbonero R, Fassnacht M, Capdevila J, Del Rivero J, Iliopoulos O, Huillard O, Jang R, Mai K, Artamonova E, Hallqvist A, Else T, Odeleye-Ajakaye A, Gozman A, Naik GS, Berruti A; LITESPARK-015 Investigators. Belzutifan for Advanced Pheochromocytoma or Paraganglioma. N Engl J Med. 2025 Oct 18. doi: 10.1056/NEJMoa2504964. Online ahead of print.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-6482-015
Identifier Type: OTHER
Identifier Source: secondary_id
PT2977
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2011220024
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-504853-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-005028-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6482-015
Identifier Type: -
Identifier Source: org_study_id