Tests belzutifan in advanced tumors linked to HIF-2α gene changes
Tests belzutifan in people with advanced pheochromocytoma or pancreatic neuroendocrine tumors.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bologna, Brescia, Milan, Naples, Siena, and Verona, ItalySee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- Apart from your pancreatic cancer, have you had another cancer in the last 3 years?
Source: NCT04924075, who can take part
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola (Site 0708)Bologna, ItalyTaking people
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology (Site 0701)Brescia, ItalyTaking people
- Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi (Site 0709)Milan, ItalyTaking people
- Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe (Site 0700)Milan, ItalyTaking people
- Ospedale San Raffaele-Oncologia Medica (Site 0705)Milan, ItalyNo longer taking part
- University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia (Site 0704)Naples, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica (Site 0706)Siena, ItalyTaking people
- Centro Ricerche Cliniche di Verona (Site 0703)Verona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT04924075EU 2023-504853-11-00
- Record updated
- 10 November 2026
- Original 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).Read full original descriptionShow less
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).
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.