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NCT07700758RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
15 (estimated)
First submitted
8 Jul 2026
Start date
13 Oct 2026
Primary completion date
2 Jan 2034
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07700758
EU CT number
2025-524515-37-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 15
  • From 13 Oct 2026 to the primary completion date, 2 Jan 2034
  • 19 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received prior treatment with any hypoxia inducible factor-2α inhibitor, including belzutifan
  • Has had an allogenic tissue/solid organ transplant

Other illness

  • Has a history of human immunodeficiency virus infection
  • 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 an active infection requiring systemic therapy

Lab values

  • Has clinically significant cardiac disease or electrocardiogram indicating uncontrolled cardiac condition or has congenital long QT syndrome

Other

  • 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 known active central nervous system metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
Region Hovedstaden
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Sant Joan De Deu Barcelona
Coordinator of this site? Confirm its status
Esplugues de LlobregatSpainRecruiting
Hospital Infantil Universitario Nino Jesus
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceNot yet recruiting
Centre Leon Berard
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LyonFranceNot yet recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Institut Curie
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ParisFranceNot yet recruiting
Institut Gustave Roussy
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VillejuifFranceNot yet recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyNot yet recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyNot yet recruiting
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 5973)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital-Pediatrics ( Site 5972)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
National Taiwan University Hospital ( Site 5983)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
University of Iowa ( Site 5017)
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.