Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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).
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
Quick Facts
Study Start:2021-08-12
Study Completion:2029-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California, 90048
United States
University of Iowa ( Site 0104)
Iowa City, Iowa, 52242
United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site
Baltimore, Maryland, 21287
United States
National Institutes of Health ( Site 0125)
Bethesda, Maryland, 20892
United States
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts, 02114
United States
University of Michigan ( Site 0126)
Ann Arbor, Michigan, 48109
United States
Washington University-Internal Medicine/Oncology ( Site 0124)
Saint Louis, Missouri, 63110
United States
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York, 10029
United States
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee, 37232
United States
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas, 77030
United States
Collaborators and Investigators
Sponsor: Merck Sharp & Dohme LLC
- Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2021-08-12
Study Completion Date2029-06-04
Study Record Updates
Study Start Date2021-08-12
Study Completion Date2029-06-04
Terms related to this study
Keywords Provided by Researchers
- HIF-2α
- Pheochromocytoma/paraganglioma
- Pancreatic NET
Additional Relevant MeSH Terms
- Pheochromocytoma/Paraganglioma
- Pancreatic Neuroendocrine Tumor
- Von Hippel-Lindau Disease
- Advanced Gastrointestinal Stromal Tumor
- HIF-2α Mutated Cancers