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)
Recruiting · NCT04924075 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
Belzutifan
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).
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 B1: 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
Where it is running
60 locations listed across 11 US states.
- 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
- Hacettepe Universitesi-oncology hospital ( Site 0901) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi. ( Site 0904) - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron ( Site 1100) - Barcelona, Spain
- Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503) - Berlin, Germany
- 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
- Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600) - Budapest, Hungary
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902) - Istanbul, Turkey (Türkiye)
- Kyoto University Hospital ( Site 1806) - Kyoto, Japan
- 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
- Oslo Universitetssykehus Radiumhospitalet ( Site 2400) - Oslo, Norway
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404) - Paris, France
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600) - Porto, Portugal
- Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400) - Ramat Gan, Israel
- Sourasky Medical Center ( Site 1401) - Tel Aviv, Israel
- Tokyo Women's Medical University Adachi Medical Center ( Site 1803) - Tokyo, Japan
- Universitair Medisch Centrum Utrecht ( Site 1530) - Utrecht, Netherlands
- Centro Ricerche Cliniche di Verona ( Site 0703) - Verona, Italy
- Baskent University Adana Training Hospital ( Site 0906) - Yüreğir, Adana, Turkey (Türkiye)
- Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203) - Calgary, Alberta, Canada
- CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402) - Strasbourg, Alsace, France
- Hôpital Edouard Herriot-oncologie ( Site 0405) - Lyon, Auvergne-Rhône-Alpes, France
- Universitaetsklinikum Freiburg ( Site 0504) - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- GBUZ Republican Clinical Oncological Dispensary ( Site 0804) - Ufa, Baskortostan, Respublika, Russia
- 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
- Peking University First Hospital-Urology ( Site 1900) - Beijing, Beijing Municipality, China
- Institut Paoli-Calmettes-Oncology ( Site 0406) - Marseille, Bouches-du-Rhone, France
- Addenbrooke's Hospital ( Site 1309) - Cambridge, Cambridgeshire, United Kingdom
- University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704) - Naples, Campania, Italy
- Rigshospitalet ( Site 0304) - Copenhagen, Capital Region, Denmark
- Rigshospitalet-Department of Endocrinology ( Site 0303) - Copenhagen, Capital Region, Denmark
- National Cancer Centre Singapore ( Site 1700) - Singapore, Central Singapore, Singapore
- Royal Free Hospital ( Site 1302) - London, England, United Kingdom
- The Beatson West of Scotland Cancer Centre ( Site 1308) - Glasgow, Glasgow City, United Kingdom
- Sun Yat-sen University Cancer Center ( Site 1905) - Guangzhou, Guangdong, China
- 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
- 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
- START Lisbon - Hospital de Santa Maria ( Site 2601) - Lisbon, Lisbon District, Portugal
- Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709) - Milan, Lombardy, Italy
- Hammersmith Hospital-Medical Oncology ( Site 1304) - London, London, City of, United Kingdom
- MD Anderson Cancer Center-Oncology ( Site 1102) - Madrid, Madrid, Comunidad de, Spain
Showing 60 of 84 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →