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

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Cedars-Sinai Medical Center ( Site 0110)90048Los AngelesCalifornia
University of Iowa ( Site 0104)52242Iowa CityIowa
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site21287BaltimoreMaryland
National Institutes of Health ( Site 0125)20892BethesdaMaryland
Massachusetts General Hospital ( Site 0111)02114BostonMassachusetts
University of Michigan ( Site 0126)48109Ann ArborMichigan
Washington University-Internal Medicine/Oncology ( Site 0124)63110Saint LouisMissouri
Icahn School of Medicine at Mount Sinai ( Site 0123)10029New YorkNew York
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)19104PhiladelphiaPennsylvania
Vanderbilt University Medical Center ( Site 0107)37232NashvilleTennessee

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.