Trials / Recruiting
RecruitingNCT04924075
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)
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 322 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Pheochromocytoma/Paraganglioma
- Pancreatic Neuroendocrine Tumor
- Von Hippel-Lindau Disease
- Advanced Gastrointestinal Stromal Tumor
- HIF-2α Mutated Cancers
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belzutifan | Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation. |
Timeline
- Start date
- 2021-08-12
- Primary completion
- 2029-06-04
- Completion
- 2029-06-04
- First posted
- 2021-06-11
- Last updated
- 2026-04-13
Locations
84 sites across 22 countries: United States, Australia, Canada, Chile, China, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Norway, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04924075. Inclusion in this directory is not an endorsement.