Trial NCT04924075
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)
- Phase
- Phase 2
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Pheochromocytoma/Paraganglioma; Pancreatic Neuroendocrine Tumor; Von Hippel-Lindau Disease; Advanced Gastrointestinal Stromal Tumor; HIF-2α Mutated Cancers
- Ages
- 12+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 yearsPrior malignancy
* 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 failureCardiac
* 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
Restrictions found (2)
- CardiacConditionalexclusion
CABG/PTCA ≤6 months; NYHA Class III or IV
Show in the text - Prior malignancyConditionalexclusion
no evidence of malignancy for 2 years
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital ( Site 0111) · Boston, Suffolk County