Belzutifan in adolescents with solid tumors

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 is a phase 2 interventional trial evaluating the safety and tolerability of belzutifan in adolescents with locally advanced, unresectable, or metastatic solid tumors including pheochromocytoma/paraganglioma, wild-type GIST, and VHL-associated tumors. Participants receive belzutifan and are monitored for safety and how well they tolerate the treatment. Eligibility requires measurable disease and specific health criteria to minimize risk, with exclusion for significant cardiac, oxygenation, infectious, or prior HIF-2α inhibitor exposure. The study is conducted across multiple international sites under Merck Sharp & Dohme, with oversight for adverse events and dose management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a diagnosis of one of the following: locally advanced, unresectable, or metastatic pheochromocytoma/paraganglioma or wild-type gastrointestinal stromal tumors, or localized tumors associated with von Hippel-Lindau disease
* Has measurable disease per RECIST 1.1

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Has clinically significant cardiac disease or electrocardiogram indicating uncontrolled cardiac condition or has congenital long QT syndrome
* Has a history of human immunodeficiency virus infection
* Has received prior treatment with any hypoxia inducible factor-2α inhibitor, including belzutifan
* Has had an allogenic tissue/solid organ transplant
* Has a history of autologous stem cell transplant within 6 months of start of study intervention
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has known active central nervous system metastases and/or carcinomatous meningitis
* Has an active infection requiring systemic therapy

Where it's running

• University of Iowa ( Site 5017)
  Iowa City, Iowa, United States Recruiting
• UZ Gent ( Site 5428)
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• Rigshospitalet ( Site 5467)
  Copenhagen, Capital Region, Denmark Recruiting
• Centre Hospitalier Universitaire de Nantes - Hopital Mere Enfant ( Site 5104)
  Nantes, Loire-Atlantique, France Recruiting
• Seoul National University Hospital-Pediatrics ( Site 5972)
  Seoul, South Korea Recruiting
• Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 5973)
  Seoul, South Korea Recruiting

Study contacts

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

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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.