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)

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

12 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

355 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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, 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (85)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

85 locations

Study team and timeline

Lead sponsor

Merck Sharp & Dohme LLC

Study start

Aug 12, 2021 Actual

Primary completion

Nov 18, 2032 Estimated

Study completion

Nov 18, 2032 Estimated

First posted

Jun 11, 2021 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts