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)

Last updated: May 2, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Neuroendocrine Carcinoma

Solid Tumors

Treatment

Belzutifan

Clinical Study ID

NCT04924075
6482-015
2023-504853-11
2020-005028-13
2023-504853-11-00
jRCT2011220024
MK-6482-015
PT2977
  • Ages > 12
  • All Genders

Study 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

Inclusion

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 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

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

Study Design

Total Participants: 322
Treatment Group(s): 1
Primary Treatment: Belzutifan
Phase: 2
Study Start date:
August 12, 2021
Estimated Completion Date:
June 04, 2029

Connect with a study center

  • Prince of Wales Hospital-Medical Oncology ( Site 1601)

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital ( Site 1602)

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Tom Baker Cancer Center ( Site 0203)

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Centro de Oncología de Precisión ( Site 2203)

    Santiago, Region M. De Santiago 7560908
    Chile

    Active - Recruiting

  • FALP ( Site 2200)

    Santiago, Region M. De Santiago 7500921
    Chile

    Active - Recruiting

  • Peking University First Hospital-Urology ( Site 1900)

    Beijing, Beijing 100034
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center ( Site 1905)

    Guangzhou, Guangdong 510700
    China

    Active - Recruiting

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)

    Shanghai, Shanghai 200001
    China

    Site Not Available

  • West China Hospital of Sichuan University ( Site 1906)

    Cheng Du, Sichuan 610041
    China

    Completed

  • Rigshospitalet ( Site 0304)

    Copenhagen, Hovedstaden 2100
    Denmark

    Active - Recruiting

  • Rigshospitalet-Department of Endocrinology ( Site 0303)

    Copenhagen, Hovedstaden 2100
    Denmark

    Active - Recruiting

  • Odense Universitetshospital ( Site 0302)

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • Odense Universitetshospital ( Site 0302)

    Odense C, Syddanmark 5000
    Denmark

    Active - Recruiting

  • CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)

    Strasbourg, Alsace 67098
    France

    Active - Recruiting

  • Institut Paoli-Calmettes-Oncology ( Site 0406)

    Marseille, Bouches-du-Rhone 13009
    France

    Site Not Available

  • Gustave Roussy ( Site 0403)

    Villejuif, Ile-de-France 94805
    France

    Active - Recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)

    Le Kremlin-Bicêtre, Paris 94270
    France

    Active - Recruiting

  • Hôpital Edouard Herriot-oncologie ( Site 0405)

    Lyon, Rhone-Alpes 69003
    France

    Active - Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)

    Paris, 75014
    France

    Active - Recruiting

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (

    München, Bayern 80336
    Germany

    Completed

  • Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)

    Würzburg, Bayern 97080
    Germany

    Active - Recruiting

  • Universitaetsklinikum Freiburg ( Site 0504)

    Freiburg, Brandenburg 79106
    Germany

    Active - Recruiting

  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

    Active - Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site

    Berlin, 10117
    Germany

    Active - Recruiting

  • Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)

    Budapest, 1083
    Hungary

    Active - Recruiting

  • Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 1401)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)

    Naples, Campania 80100
    Italy

    Completed

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)

    Brescia, 25123
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe

    Milano, 20141
    Italy

    Active - Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 0705)

    Milano, 20132
    Italy

    Completed

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)

    Verona, 37134
    Italy

    Active - Recruiting

  • Hokkaido University Hospital ( Site 1800)

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Yokohama City University Hospital-Department of Urology ( Site 1804)

    Yokohama, Kanagawa 2360004
    Japan

    Site Not Available

  • Yokohama City University Hospital ( Site 1804)

    Yokohama-shi, Kanagawa 236-0004
    Japan

    Site Not Available

  • Kochi Medical School Hospital ( Site 1807)

    Nankoku, Kochi 783-8505
    Japan

    Site Not Available

  • National Cancer Center Hospital ( Site 1802)

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kyoto University Hospital ( Site 1806)

    Kyoto,
    Japan

    Site Not Available

  • Tokyo Women's Medical University Adachi Medical Center ( Site 1803)

    Tokyo, 123-8558
    Japan

    Site Not Available

  • Seoul National University Hospital ( Site 2001)

    Jongno-gu, Seoul 03080
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center ( Site 2000)

    Songpa-gu, Seoul 05505
    Korea, Republic of

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht ( Site 1530)

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Oslo Universitetssykehus Radiumhospitalet ( Site 2400)

    Oslo, 0424
    Norway

    Active - Recruiting

  • GBUZ Republican Clinical Oncological Dispensary ( Site 0804)

    Ufa, Baskortostan, Respublika 450054
    Russian Federation

    Suspended

  • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

    Saint Petersburg, Leningradskaya Oblast 190020
    Russian Federation

    Completed

  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)

    Saint Petersburg, Leningradskaya Oblast 198255
    Russian Federation

    Suspended

  • Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)

    Moscow, Moskva 117036
    Russian Federation

    Completed

  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)

    Moscow, Moskva 115522
    Russian Federation

    Suspended

  • National Cancer Centre Singapore ( Site 1700)

    Singapore, Central Singapore 168583
    Singapore

    Active - Recruiting

  • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)

    Madrid, Madrid, Comunidad De 28041
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center-Oncology ( Site 1102)

    Madrid, Madrid, Comunidad De 28033
    Spain

    Completed

  • Hospital Universitari Vall d'Hebron ( Site 1100)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Skanes University Hospital Lund ( Site 1200)

    Lund, Skane Lan 221 85
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 1202)

    Stockholm, Stockholms Lan 171 76
    Sweden

    Completed

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)

    Uppsala, Uppsala Lan 751 85
    Sweden

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)

    Gothenburg, Vastra Gotalands Lan 413 45
    Sweden

    Active - Recruiting

  • Baskent University Adana Training Hospital ( Site 0906)

    Yuregir, Adana 01250
    Turkey

    Active - Recruiting

  • Baskent University Adana Training Hospital ( Site 0906)

    Yüregir, Adana 01250
    Turkey

    Site Not Available

  • Ege University Medicine of Faculty ( Site 0900)

    Bornova, Izmir 35100
    Turkey

    Active - Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 0904)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Ankara City Hospital ( Site 0904)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universitesi-oncology hospital ( Site 0901)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)

    Istanbul, 34668
    Turkey

    Completed

  • Ege University-Tulay Aktas Oncology Department ( Site 0900)

    Izmir, 35100
    Turkey

    Site Not Available

  • Addenbrooke's Hospital ( Site 1309)

    Cambridge, Cambridgeshire CB2 2QQ
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital ( Site 1302)

    London, England NW3 2QG
    United Kingdom

    Site Not Available

  • The Beatson West of Scotland Cancer Centre ( Site 1308)

    Glasgow, Glasgow City G12 0YN
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital-Medical Oncology ( Site 1304)

    London, London, City Of W12 OHS
    United Kingdom

    Active - Recruiting

  • Cedars-Sinai Medical Center ( Site 0110)

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Iowa ( Site 0104)

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • National Institute of Health ( Site 0125)

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • National Institutes of Health ( Site 0125)

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Massachusetts General Hospital ( Site 0111)

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan ( Site 0126)

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Washington University-Internal Medicine/Oncology ( Site 0124)

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai ( Site 0123)

    New York, New York 10029
    United States

    Site Not Available

  • Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center ( Site 0107)

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center ( Site 0112)

    Houston, Texas 77030
    United States

    Active - Recruiting

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