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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Belzutifan: Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
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
Primary outcome measure(s)
- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 5.5 years
ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due to any cause, whichever occurs first.
Trial sites (84)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center ( Site 0110) | Los Angeles | California | Recruiting |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130) | Chicago | Illinois | Recruiting |
| Northwestern Medicine Cancer Center - Warrenville ( Site 0134) | Warrenville | Illinois | Recruiting |
| University of Iowa ( Site 0104) | Iowa City | Iowa | Recruiting |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108) | Baltimore | Maryland | Recruiting |
| National Institutes of Health ( Site 0125) | Bethesda | Maryland | Recruiting |
| Massachusetts General Hospital ( Site 0111) | Boston | Massachusetts | Recruiting |
| University of Michigan ( Site 0126) | Ann Arbor | Michigan | Recruiting |
| Washington University-Internal Medicine/Oncology ( Site 0124) | St Louis | Missouri | Active Not Recruiting |
| Icahn School of Medicine at Mount Sinai ( Site 0123) | New York | New York | Active Not Recruiting |
| Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127) | Philadelphia | Pennsylvania | Active Not Recruiting |
| SCRI Oncology Partners ( Site 7000) | Nashville | Tennessee | Completed |
| Vanderbilt University Medical Center ( Site 0107) | Nashville | Tennessee | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 0112) | Houston | Texas | Recruiting |
| Prince of Wales Hospital-Medical Oncology ( Site 1601) | Randwick | New South Wales | Recruiting |
| The Royal Melbourne Hospital ( Site 1602) | Parkville | Victoria | Recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203) | Calgary | Alberta | Recruiting |
| Princess Margaret Cancer Centre ( Site 0202) | Toronto | Ontario | Recruiting |
| Fundación Arturo López Pérez ( Site 2200) | Santiago | Region M. de Santiago | Recruiting |
| Centro de Oncología de Precisión ( Site 2203) | Santiago | Region M. de Santiago | Recruiting |
| Peking University First Hospital-Urology ( Site 1900) | Beijing | Beijing Municipality | Active Not Recruiting |
| Sun Yat-sen University Cancer Center ( Site 1905) | Guangzhou | Guangdong | Active Not Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904) | Shanghai | Shanghai Municipality | Active Not Recruiting |
| West China Hospital of Sichuan University ( Site 1906) | Chengdu | Sichuan | Completed |
| Rigshospitalet ( Site 0304) | Copenhagen | Capital Region | Active Not Recruiting |
| Rigshospitalet-Department of Endocrinology ( Site 0303) | Copenhagen | Capital Region | Active Not Recruiting |
| Odense Universitetshospital ( Site 0302) | Odense C | Region Syddanmark | Active Not Recruiting |
| CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402) | Strasbourg | Alsace | Recruiting |
| Hôpital Edouard Herriot-oncologie ( Site 0405) | Lyon | Auvergne-Rhône-Alpes | Recruiting |
| Institut Paoli-Calmettes-Oncology ( Site 0406) | Marseille | Bouches-du-Rhone | Active Not Recruiting |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407) | Le Kremlin-Bicêtre | Paris | Recruiting |
| Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404) | Paris | France | Recruiting |
| Gustave Roussy ( Site 0403) | Villejuif | Île-de-France Region | Active Not Recruiting |
| Universitaetsklinikum Freiburg ( Site 0504) | Freiburg im Breisgau | Baden-Wurttemberg | Recruiting |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501) | München | Bavaria | Completed |
| Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500) | Würzburg | Bavaria | Recruiting |
| Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505) | Düsseldorf | North Rhine-Westphalia | Recruiting |
| Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503) | Berlin | Germany | Recruiting |
| Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600) | Budapest | Hungary | Recruiting |
| Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400) | Ramat Gan | Israel | Recruiting |
+ 44 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04924075 on ClinicalTrials.gov ↗ ← All trials in Turkey