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)
This research study is looking at a new medicine called belzutifan for people with advanced cancers like pheochromocytoma/paraganglioma (cancers of the adrenal glands or nerve cells), pancreatic neuroendocrine tumors (a type of pancreatic cancer), certain tumors related to Von Hippel-Lindau disease, or a specific type of advanced stomach cancer (GIST). It also includes other solid cancers with particular genetic changes. The main goal is to find out how effective belzutifan is at shrinking these tumors and if it's safe to use. This is a Phase 2 study, which means it builds on earlier research to gather more information on effectiveness and safety in a larger group of people.
At a glance
What is this study about?
This study is investigating a new medication called belzutifan, which is being tested for several advanced cancers. These include rare conditions like pheochromocytoma and paraganglioma, which are types of tumors often found in the adrenal glands or along nerve pathways. It's also for a specific kind of pancreatic cancer, certain tumors that develop in people with a genetic condition called Von Hippel-Lindau (VHL) disease, and a particular type of advanced stomach cancer. Finally, it covers other solid cancers that have a specific genetic change related to something called HIF-2α.
The main idea behind this research is to see if belzutifan can help shrink these tumors or stop them from growing. We also want to understand if it's safe and how people tolerate it. This is important because these cancers can be difficult to treat, and new options are always needed. Finding effective and safe treatments can make a big difference in people's lives.
This is a 'Phase 2' study. This means that belzutifan has already been tested in smaller groups of people and shown some promising results. In this phase, we are giving the medicine to a larger group to get more detailed information about its effectiveness and safety. The information we gather will help us decide if belzutifan could become a new treatment option in the future.
Key takeaways
- This study is testing a new medicine called belzutifan for several advanced cancers.
- It aims to see if belzutifan can shrink tumors and if it is safe.
- The study includes rare cancers like pheochromocytoma, paraganglioma, and certain pancreatic and stomach cancers.
- Participants must generally be at least 12 years old, with some exceptions for older ages.
- Regular hospital visits, tests, and scans will be part of the study monitoring.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, participants generally need to be at least 12 years old, though for certain tumors related to Von Hippel-Lindau disease, you must be 18 or older. You must have one of the specific advanced cancers that the study is focusing on, and your doctors must believe you have at least three months to live.
There are also some reasons why you might not be able to join. For example, if you can't swallow pills, have trouble absorbing medicines, or have had another cancer in the last two years that wasn't fully cured. Your breathing and heart health are also important; if you need continuous oxygen or have serious heart problems, you might not be suitable.
Finally, if you've recently had other cancer treatments like chemotherapy, targeted drugs, or biological therapies within the last four weeks (except certain specific drugs for hormone-related issues), you would not be able to participate at this time.
- Are you at least 12 years old (or 18 for certain conditions)?
- Do you have advanced pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumor, VHL disease-associated tumors, or a specific type of advanced stomach cancer, or another solid cancer with a HIF-2α genetic change?
- Can you swallow pills without difficulty?
- Have you avoided other cancer treatments (except certain specific ones) in the last four weeks?
- Do you not require continuous oxygen and don't have severe heart problems?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the study medication, belzutifan. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. These assessments help the doctors understand if the medicine is working and if there are any side effects. The exact number and frequency of visits will be explained by the study team, but they are designed to closely monitor your health and the progress of your cancer. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it could involve ongoing treatment and follow-up for several months or longer.
Potential risks and benefits
Locations (84)
- Cedars-Sinai Medical Center ( Site 0110)Los Angeles, United States· Recruiting
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)Chicago, United States· Recruiting
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134)Warrenville, United States· Recruiting
- University of Iowa ( Site 0104)Iowa City, United States· Recruiting
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)Baltimore, United States· Recruiting
- National Institutes of Health ( Site 0125)Bethesda, United States· Recruiting
- Massachusetts General Hospital ( Site 0111)Boston, United States· Recruiting
- University of Michigan ( Site 0126)Ann Arbor, United States· Recruiting
- Washington University-Internal Medicine/Oncology ( Site 0124)St Louis, United States· Active not recruiting
- Icahn School of Medicine at Mount Sinai ( Site 0123)New York, United States· Active not recruiting
- Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)Philadelphia, United States· Recruiting
- SCRI Oncology Partners ( Site 7000)Nashville, United States· Recruiting
+72 more sites — see the official record for the full list.
Common questions
What is belzutifan?
Belzutifan is a new drug being tested in this study to see how it affects certain advanced cancers.
What types of cancer is this study for?
This study is for specific types of advanced cancers such as rare adrenal gland or nerve cell tumors, certain pancreatic and stomach cancers, and tumors linked to Von Hippel-Lindau disease, or other cancers with specific genetic changes.
What happens in a Phase 2 study?
In a Phase 2 study, a new medicine is given to a larger group of people to gather more details about how well it works and its safety.
Can children join this study?
Yes, some parts of the study are open to participants aged 12 and older, but for certain conditions, you must be at least 18.
Will I still receive my regular medical care?
Yes, taking part in a study will not affect your right to receive your usual medical care, and you can leave the study at any point.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.