Study

Overview

Official Title: 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

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).

Study Type:

Interventional

Study Phase:

Phase 2

Estimated Enrollment:

355

Study Start Date:

August 2021

Estimated Study Completion Date:

December 2029

Estimated Primary Completion Date:

December 2029

Eligibility

Ages Eligible for Study:

12 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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 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

Locations

United States Toll Free Number 1-800-770-4674

Los Angeles, California, 90048
Chicago, Illinois, 60611
Warrenville, Illinois, 60555
Iowa City, Iowa, 52242
Baltimore, Maryland, 21287
Bethesda, Maryland, 20892
Boston, Massachusetts, 02114
Ann Arbor, Michigan, 48109
Nashville, Tennessee, 37203
Nashville, Tennessee, 37232
Houston, Texas, 77030

Canada Study Coordinator 403-521-3165

Results

No Study Results Posted

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results