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)

Launched by MERCK SHARP & DOHME LLC · Jun 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called belzutifan for patients with certain advanced tumors, including pheochromocytoma, paraganglioma, pancreatic neuroendocrine tumors, and other solid tumors linked to specific genetic changes. The main goal of the study is to see how well this treatment works and to assess its safety. Participants will be closely monitored to evaluate their response to the treatment.

To be eligible for this trial, participants must have specific types of tumors that are not suitable for surgery and must have had some previous treatment. They also need to have controlled blood pressure and meet other health criteria. If someone joins the study, they can expect regular visits to the clinic for treatment and check-ups. This trial is currently looking for patients of all ages, and it’s a chance for those with limited options to contribute to research that could help improve future cancer treatments.

Gender

ALL

Eligibility criteria

• 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