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
Merck Sharp & Dohme LLC
Summary
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).
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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 di…
Interventions
- DrugBelzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Locations (84)
- Cedars-Sinai Medical Center ( Site 0110)Los Angeles, California
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)Chicago, Illinois
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134)Warrenville, Illinois
- University of Iowa ( Site 0104)Iowa City, Iowa
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)Baltimore, Maryland
- National Institutes of Health ( Site 0125)Bethesda, Maryland