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

Condition(s) studied

Investigational drug(s) / intervention(s)

Belzutifan: Administered once daily via oral tablet

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.

Eligibility

Primary outcome measure(s)

• Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 5 years
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that experience AEs will be reported.
• Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 5 years
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that discontinue study intervention due to an AE will be reported.

Trial sites (1)

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