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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)

355 patients around the world

Available in Spain, Chile, United States, Argentina

Merck Sharp & Dohme LLC

1Research sites

355Patients around the world

This study is for people with

Neuroendocrine tumor

Pancreatic neuroendocrine tumor

Gastrointestinal stromal tumors

Solid tumors

From 12 Years

All Gender

: 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 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.

: 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.

Centro Oncológico Korben

Recruiting

Cdad. de La Paz 353, C1426 CABA, Argentina

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Pancreatic neuroendocrine tumorGastrointestinal stromal tumorsSolid tumors

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT04924075