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)
Start Date
8/12/2021
Completion Date
12/27/2029
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).
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Belzutifan
Conditions
Locations
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California 90048
United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago, Illinois 60611
United States
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Warrenville, Illinois 60555
United States
University of Iowa ( Site 0104)
Iowa City, Iowa 52242
United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Baltimore, Maryland 21287
United States
National Institutes of Health ( Site 0125)
Bethesda, Maryland 20892
United States
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts 02114
United States
University of Michigan ( Site 0126)
Ann Arbor, Michigan 48109
United States
Washington University-Internal Medicine/Oncology ( Site 0124)
St Louis, Missouri 63110
United States
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York 10029
United States
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania 19104
United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee 37232
United States
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas 77030
United States
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick, New South Wales 2031
Australia
The Royal Melbourne Hospital ( Site 1602)
Parkville, Victoria 3050
Australia
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary, Alberta T2N 5G2
Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario M5G 2M9
Canada
FALP ( Site 2200)
Santiago, Region M. de Santiago 7500921
Chile
Centro de Oncología de Precisión ( Site 2203)
Santiago, Region M. de Santiago 7560908
Chile
Peking University First Hospital-Urology ( Site 1900)
Beijing, Beijing Municipality 100034
China
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou, Guangdong 510060
China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai, Shanghai Municipality 200001
China
West China Hospital of Sichuan University ( Site 1906)
Chengdu, Sichuan 610041
China
Rigshospitalet ( Site 0304)
Copenhagen, Capital Region 2100
Denmark
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen, Capital Region 2100
Denmark
Odense Universitetshospital ( Site 0302)
Odense, Region Syddanmark 5000
Denmark
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg, Alsace 67098
France
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon, Auvergne-Rhône-Alpes 69003
France
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille, Bouches-du-Rhone 13009
France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre, Paris 94270
France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris, 75014
France
Gustave Roussy ( Site 0403)
Villejuif, Île-de-France Region 94805
France
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg im Breisgau, Baden-Wurttemberg 79106
Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
München, Bavaria 80336
Germany
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg, Bavaria 97080
Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf, North Rhine-Westphalia 40225
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Berlin, 10117
Germany
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest, 1083
Hungary
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan, 5262100
Israel
Sourasky Medical Center ( Site 1401)
Tel Aviv, 6423906
Israel
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples, Campania 80100
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Milan, Lombardy 20133
Italy
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Siena, Tuscany 53100
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna, 40138
Italy
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia, 25123
Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milan, 20132
Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Milan, 20141
Italy
Centro Ricerche Cliniche di Verona ( Site 0703)
Verona, 37134
Italy
Hokkaido University Hospital ( Site 1800)
Sapporo, Hokkaido 060-8648
Japan
Yokohama City University Hospital ( Site 1804)
Yokohama, Kanagawa 236-0004
Japan
Kochi Medical School Hospital ( Site 1807)
Nankoku, Kochi 783-8505
Japan
National Cancer Center Hospital ( Site 1802)
Chuo-ku, Tokyo 104-0045
Japan
Kyoto University Hospital ( Site 1806)
Kyoto, 606-8507
Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo, 123-8558
Japan
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht, 3584 CX
Netherlands
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo, 0424
Norway
START Lisbon - Hospital de Santa Maria ( Site 2601)
Lisbon, Lisbon District 1649-035
Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Porto, 4200-072
Portugal
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa, Baskortostan, Respublika 450054
Russia
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
Saint Petersburg, Leningradskaya Oblast' 190020
Russia
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg, Leningradskaya Oblast' 198255
Russia
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow, Moscow 115522
Russia
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow, Moscow 117036
Russia
National Cancer Centre Singapore ( Site 1700)
Singapore, Central Singapore 168583
Singapore
Seoul National University Hospital ( Site 2001)
Jongno-gu, Seoul 03080
South Korea
Asan Medical Center ( Site 2000)
Songpa-gu, Seoul 05505
South Korea
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid, Madrid, Comunidad de 28033
Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid, Madrid, Comunidad de 28041
Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo, Principality of Asturias 33011
Spain
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona, 08035
Spain
Skanes University Hospital Lund ( Site 1200)
Lund, Skåne County 221 85
Sweden
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm, Stockholm County 171 76
Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala, Uppsala County 751 85
Sweden
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg, Västra Götaland County 413 45
Sweden
Baskent University Adana Training Hospital ( Site 0906)
Yüreğir, Adana 01250
Turkey (Türkiye)
Ege University Medicine of Faculty ( Site 0900)
Bornova, İzmir 35100
Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara, 06800
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul, 34668
Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1309)
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
Royal Free Hospital ( Site 1302)
London, England NW3 2QG
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow, Glasgow City G12 0YN
United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 1304)
London, London, City of W12 OHS
United Kingdom