A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01)
Malignant Neoplasm
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 12 años - 17 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 15 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
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
Exclusion Criteria:
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 clinically significant cardiac disease or electrocardiogram indicating uncontrolled cardiac condition or has congenital long QT syndrome
- Has a history of human immunodeficiency virus infection
- Has received prior treatment with any hypoxia inducible factor-2α inhibitor, including belzutifan
- Has had an allogenic tissue/solid organ transplant
- 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 known active central nervous system metastases and/or carcinomatous meningitis
- Has an active infection requiring systemic therapy
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Drug: Belzutifan
Belzutifan DRUG
Administered once daily via oral tablet
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Participants Who Experience One or More Adverse Events (AEs)
Plazo: 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
Plazo: 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.
Medidas secundarias
Area Under the Concentration-Time Curve From Time 0 to 24 hours of Belzutifan
Plazo: At designated timepoints (up to 5 weeks)
Blood samples will be collected at specified intervals to determine the area under the concentration-time curve from time 0 to 24 hours of belzutifan.
Minimum Plasma Concentration (Cmin) of Belzutifan
Plazo: At designated timepoints (up to 5 weeks)
Blood samples will be collected at specified intervals to determine the Cmin of belzutifan.
Maximum Plasma Concentration (Cmax) of Belzutifan
Plazo: At designated timepoints (up to 5 weeks)
Blood samples will be collected at specified intervals to determine the Cmax of belzutifan.
Objective Response Rate (ORR)
Plazo: Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator will be reported.
Duration of Response (DOR)
Plazo: Up to approximately 5 years
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be reported.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (10)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
10 centros
University of Iowa ( Site 5017)Iowa City, Iowa, United StatesReclutando
UZ Gent ( Site 5428)Ghent, Oost-Vlaanderen, BelgiumReclutando
Rigshospitalet ( Site 5467)Copenhagen, Capital Region, DenmarkReclutando
Centre Hospitalier Universitaire de Nantes - Hopital Mere Enfant ( Site 5104)Nantes, Loire-Atlantique, FranceReclutando
Seoul National University Hospital-Pediatrics ( Site 5972)Seoul, South KoreaReclutando
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 5973)Seoul, South KoreaReclutando
Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 5717)Esplugas de Llobregat, Barcelona, SpainReclutando
Hospital Universitari Vall d Hebron ( Site 5716)Barcelona, SpainReclutando
Hospital Infantil Universitario Nino Jesus ( Site 5715)Madrid, SpainReclutando
National Taiwan University Hospital ( Site 5983)Taipei, TaiwanReclutando
Equipo y fechas
- Patrocinador principal
- Merck Sharp & Dohme LLC
- Inicio del estudio
- 13 oct 2026 Real
- Finalización primaria
- 2 ene 2034 Estimado
- Finalización del estudio
- 2 ene 2034 Estimado
- Primera publicación
- 14 jul 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
LIGHTBEAM-U01 Substudy 01E: A Phase 2 Substudy to Evaluate the Safety and Efficacy of Belzutifan in Participants With Solid Tumors
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026