A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07700758
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Administered once daily via oral tablet

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Nov 23, 2026
Status verified
Jul 2026
Primary completion
Jan 2, 2034
Completion
Jan 2, 2034

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]

Related Studies