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
Who is this study for? Patients with advanced pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumor, or Von Hippel-Lindau disease-associated tumors
What treatments are being studied? Belzutifan
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cedars-Sinai Medical Center ( Site 0110)
RECRUITING
Los Angeles
Iowa
University of Iowa ( Site 0104)
RECRUITING
Iowa City
Illinois
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital ( Site 0111)
RECRUITING
Boston
Maryland
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
RECRUITING
Baltimore
National Institutes of Health ( Site 0125)
RECRUITING
Bethesda
Michigan
University of Michigan ( Site 0126)
RECRUITING
Ann Arbor
Missouri
Washington University-Internal Medicine/Oncology ( Site 0124)
ACTIVE_NOT_RECRUITING
St Louis
New York
Icahn School of Medicine at Mount Sinai ( Site 0123)
ACTIVE_NOT_RECRUITING
New York
Pennsylvania
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
RECRUITING
Philadelphia
Tennessee
SCRI Oncology Partners ( Site 7000)
RECRUITING
Nashville
Vanderbilt University Medical Center ( Site 0107)
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center ( Site 0112)
RECRUITING
Houston
Other Locations
Australia
The Royal Melbourne Hospital ( Site 1602)
RECRUITING
Parkville
Prince of Wales Hospital-Medical Oncology ( Site 1601)
RECRUITING
Randwick
Canada
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
RECRUITING
Calgary
Princess Margaret Cancer Centre ( Site 0202)
RECRUITING
Toronto
Chile
Centro de Oncología de Precisión ( Site 2203)
RECRUITING
Santiago
FALP ( Site 2200)
RECRUITING
Santiago
China
Peking University First Hospital-Urology ( Site 1900)
ACTIVE_NOT_RECRUITING
Beijing
West China Hospital of Sichuan University ( Site 1906)
COMPLETED
Chengdu
Sun Yat-sen University Cancer Center ( Site 1905)
RECRUITING
Guangzhou
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
ACTIVE_NOT_RECRUITING
Shanghai
Denmark
Rigshospitalet ( Site 0304)
RECRUITING
Copenhagen
Rigshospitalet-Department of Endocrinology ( Site 0303)
RECRUITING
Copenhagen
Odense Universitetshospital ( Site 0302)
RECRUITING
Odense C
France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
RECRUITING
Le Kremlin-bicêtre
Hôpital Edouard Herriot-oncologie ( Site 0405)
RECRUITING
Lyon
Institut Paoli-Calmettes-Oncology ( Site 0406)
COMPLETED
Marseille
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
RECRUITING
Paris
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
RECRUITING
Strasbourg
Gustave Roussy ( Site 0403)
RECRUITING
Villejuif
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
RECRUITING
Düsseldorf
Universitaetsklinikum Freiburg ( Site 0504)
RECRUITING
Freiburg
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
COMPLETED
München
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
RECRUITING
Würzburg
Hungary
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
RECRUITING
Budapest
Israel
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 1401)
RECRUITING
Tel Aviv
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
RECRUITING
Brescia
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
RECRUITING
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
COMPLETED
Milan
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
COMPLETED
Naples
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
RECRUITING
Siena
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
RECRUITING
Verona
Japan
National Cancer Center Hospital ( Site 1802)
ACTIVE_NOT_RECRUITING
Chuo-ku
Kyoto University Hospital ( Site 1806)
ACTIVE_NOT_RECRUITING
Kyoto
Kochi Medical School Hospital ( Site 1807)
ACTIVE_NOT_RECRUITING
Nankoku
Hokkaido University Hospital ( Site 1800)
ACTIVE_NOT_RECRUITING
Sapporo
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
ACTIVE_NOT_RECRUITING
Tokyo
Yokohama City University Hospital ( Site 1804)
ACTIVE_NOT_RECRUITING
Yokohama
Netherlands
Universitair Medisch Centrum Utrecht ( Site 1530)
RECRUITING
Utrecht
Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
RECRUITING
Oslo
Portugal
START Lisbon - Hospital de Santa Maria ( Site 2601)
RECRUITING
Lisbon
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
RECRUITING
Porto
Republic of Korea
Seoul National University Hospital ( Site 2001)
RECRUITING
Jongno-gu
Asan Medical Center ( Site 2000)
RECRUITING
Songpa-gu
Russian Federation
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
COMPLETED
Moscow
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
RECRUITING
Moscow
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
COMPLETED
Saint Petersburg
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
RECRUITING
Saint Petersburg
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
RECRUITING
Ufa
Singapore
National Cancer Centre Singapore ( Site 1700)
RECRUITING
Singapore
Spain
Hospital Universitari Vall d'Hebron ( Site 1100)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
ACTIVE_NOT_RECRUITING
Madrid
MD Anderson Cancer Center-Oncology ( Site 1102)
COMPLETED
Madrid
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
RECRUITING
Oviedo
Sweden
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
RECRUITING
Gothenburg
Skanes University Hospital Lund ( Site 1200)
RECRUITING
Lund
Karolinska Universitetssjukhuset Solna ( Site 1202)
COMPLETED
Stockholm
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
RECRUITING
Uppsala
Turkey
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
RECRUITING
Ankara
Hacettepe Universitesi-oncology hospital ( Site 0901)
RECRUITING
Ankara
Ege University Medicine of Faculty ( Site 0900)
RECRUITING
Bornova
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
COMPLETED
Istanbul
Baskent University Adana Training Hospital ( Site 0906)
RECRUITING
Yüreğir
United Kingdom
Addenbrooke's Hospital ( Site 1309)
RECRUITING
Cambridge
The Beatson West of Scotland Cancer Centre ( Site 1308)
RECRUITING
Glasgow
Hammersmith Hospital-Medical Oncology ( Site 1304)
RECRUITING
London
Royal Free Hospital ( Site 1302)
COMPLETED
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2021-08-12
Estimated Completion Date: 2029-06-04
Participants
Target number of participants: 322
Treatments
Experimental: Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC