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LIGHTBEAM-U01 Substudy 01E: A Phase 2 Substudy to Evaluate the Safety and Efficacy of Belzutifan in Participants With Solid Tumors

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Researchers are looking for new ways to treat adolescents with locally advanced, unresectable, or metastatic solid tumors. Participants were enrolled into pheochromocytoma/paraganglioma (PPGL), wild type gastrointestinal stromal tumor (wtGIST), and Von Hippel-Lindau (VHL) disease-associated localized tumors cohorts: * PPGL are rare cancers that start in cells that make hormones in the adrenal glands * wtGIST is a less common type of cancer that starts in the digestive tract. Wild type means it does not have certain gene mutations (changes) * VHL disease-associated localized tumors are rare tumors caused by a certain gene mutation that may be passed down from parents to children * Locally advanced means the cancer has spread into nearby tissue * Unresectable means the cancer cannot be removed by surgery * Metastatic means the cancer has spread to other parts of the body The goal of the study is to learn about the safety of belzutifan and if people tolerate it.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Iowa
University of Iowa ( Site 5017)
RECRUITING
Iowa City
Other Locations
Belgium
UZ Gent ( Site 5428)
RECRUITING
Ghent
Republic of Korea
Seoul National University Hospital-Pediatrics ( Site 5972)
RECRUITING
Seoul
Spain
Hospital Infantil Universitario Nino Jesus ( Site 5715)
RECRUITING
Madrid
Contact Information
Primary
Toll Free Number
Trialsites@merck.com
1-888-577-8839
Time Frame
Start Date: 2026-10-13
Estimated Completion Date: 2034-01-02
Participants
Target number of participants: 15
Treatments
Experimental: Belzutifan
Participants will receive belzutifan 80 mg (body weight \<40 kg) or 120 mg (body weight ≥40 kg) orally once daily for approximately 2 years.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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