Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
août 2021
juin 2029
29 mai 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Study Coordinator | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Study Coordinator | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402) - 67098 - Strasbourg - Alsace - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot-oncologie ( Site 0405) - 69003 - Lyon - Rhone-Alpes - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes-Oncology ( Site 0406) - 13009 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 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
- 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 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