A phase II clinical trial is investigating the safety and effectiveness of the drug belzutifan (also called MK-6482 and formerly referred to as PT2977) for pancreatic neuroendocrine tumors (pNETs) and pheochromocytoma/paraganglioma (PPGL). To be eligible for the study, participants must have advanced or metastatic PPGL or pNET disease. Patients who have PPGL need not have received any prior treatment; however, patients who have pNETs must have progressed on prior sunitinib or everolimus.
The global study is being conducted by Merck; however, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center is the first site worldwide to open the study. Satya Das, MD, MSCI, at Vanderbilt University Medical Center is leading the clinical trial at the site.
All participants who are determined to be eligible for the study after a screening period will enter the treatment phase and receive belzutifan (MK-6482), which is taken once daily by mouth. Participation involves visits to the study site and includes a safety follow-up period after a participant leaves the study or the trial ends.
An estimated 140 people who have advanced or metastatic PPGL (N=70) or pNET (N=70) are being recruited to participate in the trial.
About the drug
The clinical trial is testing the experimental drug belzutifan (MK-6482), a small molecule that may help to attack cancer cells by interfering with the binding of hypoxia-inducible factors HIF-2α and HIF-1B. Researchers believe HIF-2α plays a key role in tumor formation and progression in cancers like PPGL and pNET. HIF-2α can bind with HIF-1B in certain conditions and lead to an increase in blood vessels and other growth pathways that may help tumors grow and keep them from dying naturally.
The study drug belzutifan (MK-6482) aims to block HIF-2α and HIF-1B from binding to each other, may prevent tumor cells from growing and allow a cell to go through its natural lifecycle. The drug has shown positive activity in a prior trial in renal cancer. In that study, a small proportion of patients also possessed pNETs. In these patients, the drug resulted in a significant anti-tumor response as well. Merck Sharp & Dohme Corp., which is a subsidiary of Merck & Co., Inc. is sponsoring the trial of belzutifan (MK-6482).
Interested participants should talk to their treatment team about their eligibility and determine if the study is aligned with their treatment goals.