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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
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).
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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
322
Start Date
2021-08-12
Completion Date
2029-06-04
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Locations (84)
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
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Warrenville, 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, 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