Treatment of advanced tumors with belzutifan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of belzutifan, a medication targeting hypoxia inducible factor-2 alpha (HIF-2α), in patients with advanced pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumors, von Hippel-Lindau disease-associated tumors, advanced gastrointestinal stromal tumors, or solid tumors with HIF-2α related genetic alterations. The primary objective is to assess the objective response rate (ORR) of belzutifan using established response evaluation criteria. Participants will be monitored for safety and treatment response through blinded independent central review.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai Medical Center ( Site 0110)
  Los Angeles, California, United States Recruiting
• Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
  Chicago, Illinois, United States Recruiting
• Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
  Warrenville, Illinois, United States Recruiting
• University of Iowa ( Site 0104)
  Iowa City, Iowa, United States Recruiting
• Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
  Baltimore, Maryland, United States Recruiting
• National Institutes of Health ( Site 0125)
  Bethesda, Maryland, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world belzutifan outcomes and pharmacogenetics in von Hippel-Lindau syndrome

  This study will test belzutifan in people aged 14 and older with VHL syndrome to see how well it controls VHL-associated tumors, what side effects occur, and how genetic factors affect response.

  Recruiting Phase 2 AC Camargo Cancer Center · São Paulo, São Paulo · NCT07167329

• Investigating genetic factors in childhood cancer

  This study is trying to find out if certain genes passed down in families can increase the risk of childhood cancer by looking at samples from kids who have had cancer and their relatives.

  Recruiting St. Jude Children's Research Hospital · Memphis, Tennessee · NCT03050268

• Belzutifan and catecholamine metabolism in pheochromocytoma/paraganglioma

  This study tests whether Belzutifan can change how catecholamines are produced and broken down in adults with pheochromocytoma or paraganglioma.

  Recruiting Phase 2 Cambridge University Hospitals NHS Foundation Trust · Cambridge, Cambridgeshire · NCT07680205

• CAIX-targeted 18F-T2 PET/CT imaging in solid tumors

  This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07557225

• AI-guided decision support for managing pancreatic conditions

  This project will test an AI tool that reads contrast-enhanced CT scans to help doctors decide whether people with suspected pancreatic disease need surgery, close monitoring, or routine follow-up.

  Recruiting Changhai Hospital · Shanghai · NCT07439757

• Extension program for people previously treated with belzutifan (MK-6482)

  This extension lets people with advanced solid tumors or VHL-related tumors who were already taking belzutifan in another study continue the drug so researchers can see how long they live and watch for long-term effects.

  Recruiting at 50 sites Phase 3 Merck Sharp & Dohme LLC · Boston, Massachusetts and 56 other locations · NCT07405164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.