Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11
322
Participants Needed
84
Research Sites
407 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
- Diagnosis of advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease-associated localized tumors, advanced wild-type gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with HIF-2α related genetic alterations
- For Cohort B1: Diagnosis of VHL disease by germline test or clinical diagnosis
- For Cohort B1: Must be at least 18 years old
- Life expectancy of at least 3 months
You will not qualify if you...
- Unable to swallow oral medication or has a disorder affecting belzutifan absorption
- History of a second cancer unless treated with no evidence of disease for at least 2 years
- Pulse oximeter reading less than 92% at rest, or requires intermittent or chronic supplemental oxygen
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction, or cardiac procedures within 6 months, or severe heart failure (NYHA Class III or IV)
- Received chemotherapy, targeted therapy, biologics, or other investigational therapy (except somatostatin analogs) within 4 weeks before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California, United States, 90048
Actively Recruiting
2
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Warrenville, Illinois, United States, 60555
Actively Recruiting
4
University of Iowa ( Site 0104)
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
National Institutes of Health ( Site 0125)
Bethesda, Maryland, United States, 20892
Actively Recruiting
7
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
University of Michigan ( Site 0126)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Washington University-Internal Medicine/Oncology ( Site 0124)
St Louis, Missouri, United States, 63110
Active, Not Recruiting
10
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York, United States, 10029
Active, Not Recruiting
11
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas, United States, 77030
Actively Recruiting
15
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick, New South Wales, Australia, 2031
Actively Recruiting
16
The Royal Melbourne Hospital ( Site 1602)
Parkville, Victoria, Australia, 3050
Actively Recruiting
17
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
18
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
19
FALP ( Site 2200)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
20
Centro de Oncología de Precisión ( Site 2203)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
21
Peking University First Hospital-Urology ( Site 1900)
Beijing, Beijing Municipality, China, 100034
Active, Not Recruiting
22
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou, Guangdong, China, 510700
Active, Not Recruiting
23
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai, Shanghai Municipality, China, 200001
Active, Not Recruiting
24
West China Hospital of Sichuan University ( Site 1906)
Chengdu, Sichuan, China, 610041
Completed
25
Rigshospitalet ( Site 0304)
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
26
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
27
Odense Universitetshospital ( Site 0302)
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
28
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg, Alsace, France, 67098
Actively Recruiting
29
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon, Auvergne-Rhône-Alpes, France, 69003
Actively Recruiting
30
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille, Bouches-du-Rhone, France, 13009
Completed
31
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre, Paris, France, 94270
Actively Recruiting
32
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris, France, 75014
Actively Recruiting
33
Gustave Roussy ( Site 0403)
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
34
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
35
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
München, Bavaria, Germany, 80336
Completed
36
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
37
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
38
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Berlin, Germany, 10117
Actively Recruiting
39
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest, Hungary, 1083
Actively Recruiting
40
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan, Israel, 5262100
Actively Recruiting
41
Sourasky Medical Center ( Site 1401)
Tel Aviv, Israel, 6423906
Actively Recruiting
42
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples, Campania, Italy, 80100
Completed
43
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Milan, Lombardy, Italy, 20133
Actively Recruiting
44
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Siena, Tuscany, Italy, 53100
Actively Recruiting
45
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna, Italy, 40138
Actively Recruiting
46
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia, Italy, 25123
Actively Recruiting
47
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milan, Italy, 20132
Completed
48
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Milan, Italy, 20141
Actively Recruiting
49
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
Verona, Italy, 37134
Actively Recruiting
50
Hokkaido University Hospital ( Site 1800)
Sapporo, Hokkaido, Japan, 060-8648
Active, Not Recruiting
51
Yokohama City University Hospital ( Site 1804)
Yokohama, Kanagawa, Japan, 236-0004
Active, Not Recruiting
52
Kochi Medical School Hospital ( Site 1807)
Nankoku, Kochi, Japan, 783-8505
Active, Not Recruiting
53
National Cancer Center Hospital ( Site 1802)
Chuo-ku, Tokyo, Japan, 104-0045
Active, Not Recruiting
54
Kyoto University Hospital ( Site 1806)
Kyoto, Japan, 606-8507
Active, Not Recruiting
55
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo, Japan, 123-8558
Active, Not Recruiting
56
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht, Netherlands, 3584 CX
Actively Recruiting
57
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo, Norway, 0424
Actively Recruiting
58
START Lisbon - Hospital de Santa Maria ( Site 2601)
Lisbon, Lisbon District, Portugal, 1649-035
Actively Recruiting
59
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Porto, Portugal, 4200-072
Actively Recruiting
60
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa, Baskortostan, Respublika, Russia, 450054
Completed
61
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
Saint Petersburg, Leningradskaya Oblast', Russia, 190020
Completed
62
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg, Leningradskaya Oblast', Russia, 198255
Actively Recruiting
63
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow, Moscow, Russia, 115522
Actively Recruiting
64
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow, Moscow, Russia, 117036
Completed
65
National Cancer Centre Singapore ( Site 1700)
Singapore, Central Singapore, Singapore, 168583
Actively Recruiting
66
Seoul National University Hospital ( Site 2001)
Jongno-gu, Seoul, South Korea, 03080
Actively Recruiting
67
Asan Medical Center ( Site 2000)
Songpa-gu, Seoul, South Korea, 05505
Actively Recruiting
68
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid, Madrid, Comunidad de, Spain, 28033
Completed
69
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid, Madrid, Comunidad de, Spain, 28041
Actively Recruiting
70
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
71
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona, Spain, 08035
Actively Recruiting
72
Skanes University Hospital Lund ( Site 1200)
Lund, Skåne County, Sweden, 221 85
Actively Recruiting
73
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm, Stockholm County, Sweden, 171 76
Completed
74
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala, Uppsala County, Sweden, 751 85
Actively Recruiting
75
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg, Västra Götaland County, Sweden, 413 45
Actively Recruiting
76
Baskent University Adana Training Hospital ( Site 0906)
Yüreğir, Adana, Turkey (Türkiye), 01250
Actively Recruiting
77
Ege University Medicine of Faculty ( Site 0900)
Bornova, İzmir, Turkey (Türkiye), 35100
Actively Recruiting
78
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
79
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
80
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul, Turkey (Türkiye), 34668
Completed
81
Addenbrooke's Hospital ( Site 1309)
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
82
Royal Free Hospital ( Site 1302)
London, England, United Kingdom, NW3 2QG
Completed
83
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow, Glasgow City, United Kingdom, G12 0YN
Actively Recruiting
84
Hammersmith Hospital-Medical Oncology ( Site 1304)
London, London, City of, United Kingdom, W12 OHS
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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