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 now Phase 2 NCT04924075
Run by Merck Sharp & Dohme LLC · for 12 and older · All sexes
What this study 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 join (things the study team will check)
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 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, …
Where this trial is running
- 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
+ 72 more sites.
Who to contact
Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04924075.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.