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

NCT07700758 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm

Interventions

DRUG

Belzutifan

Administered once daily via oral tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-23
Primary Completion
2034-01-02
Completion
2034-01-02
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700758 on ClinicalTrials.gov