Study on Belzutifan for Treating Advanced Tumors Related to Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Gastrointestinal Stromal Tumor, or Solid Tumors with HIF-2α Genetic Changes
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04924075
This clinical trial is testing the effectiveness and safety of the drug belzutifan in treating various advanced tumors, including those associated with pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumors, Von Hippel-Lindau disease, gastrointestinal stromal tumors, and other solid tumors with specific genetic changes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate how well belzutifan works and how safe it is for patients with advanced tumors related to pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumors, Von Hippel-Lindau disease, gastrointestinal stromal tumors, or other solid tumors with genetic changes in HIF-2α. The main goal is to see how many patients experience a reduction in tumor size according to specific medical criteria.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of advanced tumors, such as pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumors, or Von Hippel-Lindau disease-associated tumors.
- Tumors must be advanced or have spread and cannot be treated with surgery or other curative treatments.
- For certain tumors, patients must have tried other treatments without success.
- Must have measurable disease as determined by scans.
- Must be 18 years or older.
- Must have controlled blood pressure if applicable.
- Must not have tumors that require immediate surgery.
- Must agree to use effective contraception if of childbearing potential.
- Must provide a tumor sample for analysis.
- Must have a good performance status and adequate organ function.
- Must have a life expectancy of at least 3 months.
Exclusion Criteria
- Unable to swallow pills or have issues with drug absorption.
- Have another type of cancer unless treated and cancer-free for 2 years.
- Have known brain metastases or certain heart conditions.
- Have uncontrolled high blood pressure.
- Have low oxygen levels or need oxygen therapy.
- Have a psychiatric or substance abuse disorder affecting study participation.
- Have had major surgery or certain treatments recently.
- Have received certain cancer treatments or therapies recently.
- Have a known allergy to the study drug.
- Have not recovered from side effects of previous treatments.
- Have active infections or certain viral infections like HIV or hepatitis.
- Have had an organ transplant.
- Have uncontrolled symptoms from certain tumors.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Medical Center ( Site 0110) | 90048 | Los Angeles | California |
| University of Iowa ( Site 0104) | 52242 | Iowa City | Iowa |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site | 21287 | Baltimore | Maryland |
| National Institutes of Health ( Site 0125) | 20892 | Bethesda | Maryland |
| Massachusetts General Hospital ( Site 0111) | 02114 | Boston | Massachusetts |
| University of Michigan ( Site 0126) | 48109 | Ann Arbor | Michigan |
| Washington University-Internal Medicine/Oncology ( Site 0124) | 63110 | Saint Louis | Missouri |
| Icahn School of Medicine at Mount Sinai ( Site 0123) | 10029 | New York | New York |
| Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127) | 19104 | Philadelphia | Pennsylvania |
| Vanderbilt University Medical Center ( Site 0107) | 37232 | Nashville | Tennessee |
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