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
- Diseases
- Childhood cancers
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 5973) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital-Pediatrics ( Site 5972) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| National Taiwan University Hospital ( Site 5983) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| University of Iowa ( Site 5017) Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.