- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02097732
Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with a histologically-confirmed diagnosis of melanoma who have imaging findings suggestive of 1 to 4 brain metastases
- At least one lesion in the brain that is measurable, which is defined as ≥5 x 5mm (Prior craniotomy and surgical resection is allowed, as long as there is at least one remaining measurable lesion in the brain)
- Patients must be candidates for stereotactic radiosurgery (SRS) and planning to undergo SRS
- Patients must be candidates for ipilimumab as determined by the treating physician
- Patients must be neurologically asymptomatic, or very minimally symptomatic, as judged by the treating physicians
- At least 3 weeks has elapsed from any prior therapy, and the patient has recovered from side effects to ≤ grade 1 toxicities per Common Terminology Criteria (CTC) for Adverse Events
- Age > or = 18 years old
- Performance status of ECOG of 0 or 1 (ECOG is the Eastern Oncology Cooperative Group Scoring system used to quantify cancer patients' general well-being and activities of daily life; scores range from 0 to 5 where 0 is perfect health and 5 is death)
- Adequate organ and marrow function: alanine aminotransferase (ALT ) < 2.5x's upper limit of normal (ULN) of the institutional normal reference range, aspartate aminotransferase (AST) < 2.5x's ULN of the institutional normal reference range, Bilirubin < 1.5x's ULN of the institutional normal reference range, Creatinine < 2.0 milligrams per deciliter, Platelets > 50,000 per microliter
- Women of child-bearing potential must agree to use adequate contraception, defined as complete abstinence from intercourse with men or two methods
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Previous radiotherapy to the lesion(s) of interest, including prior treatment with whole brain radiation therapy (WBRT). Prior treatment with SRS is allowed if the index lesion(s) is in a different, non-contiguous location than the previously treated lesion.
- Patients who have previously received ipilimumab, PD-1 inhibitors or PD-L1 inhibitors are excluded due to the potential of effects on primary outcome
- Patients who require WBRT or surgery at the time of enrollment
- Neurologic symptoms or imaging findings that necessitate the use of steroids on the day of enrollment or in the prior 7 days
- Highly suspicious magnetic resonance imaging (MRI) or cerebrospinal fluid evidence of leptomeningeal metastases, unless all measurable disease is localized and SRS is considered the treatment of choice
- Concurrent treatment with any other anti-neoplastic drug or concurrent participation in another therapeutic clinical trial
- Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, history of allergic reaction/hypersensitivity to gadolinium)
- Women who are pregnant or are nursing
- Patients with absolute lymphocyte count of <500 cells/microliter, who are known to be HIV positive, who have clinically significant active autoimmune disease, or are receiving immunosuppression following solid organ or stem cell transplant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: B: No induction
Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses.
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Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.
Stereotactic radiosurgery is a type of focused radiation therapy.
It requires the placement of a metal frame on the head for several hours.
|
Experimental: A: Induction
Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.
|
Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.
Stereotactic radiosurgery is a type of focused radiation therapy.
It requires the placement of a metal frame on the head for several hours.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Local Control Rate
Periodo de tiempo: 6 months
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The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months. Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. |
6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Survival Rate
Periodo de tiempo: Up to 5 years
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Number of participants alive at 5 years after enrollment.
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Up to 5 years
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Regional (Intracranial) Control Rate
Periodo de tiempo: 6 months
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The proportion of patients in each arm who are free from progression in the index (radiated) lesions and free from new brain metastases at 6 months.
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6 months
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Intracranial Response Rate
Periodo de tiempo: Up to 12 months
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Response of treated (irradiated) brain metastases to combination therapy with ipilimumab and stereotactic radiosurgery using immune-related response criteria.
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Up to 12 months
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Time to Progression
Periodo de tiempo: From date of enrollment to up to 2 years
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Time to progression in the brain due to treated metastases or new brain metastases.
Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) was used to assess response.
Progression was defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 wk from the date first documented.
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From date of enrollment to up to 2 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Imaging Correlates on Dynamic-contrast Enhanced MRI of the Brain
Periodo de tiempo: 6 months
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Exploratory endpoints: Interval changes in dynamic MRI parameters such as perfusion, blood volume, vascular permeability (Ktrans), and diffusion tensor imaging; the change in 3D tumor volume.
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6 months
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Immune Correlates
Periodo de tiempo: 6 months
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Exploratory endpoints: Interval changes in immune markers in the blood
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christopher Lao, M.D., University of Michigan Rogel Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Procesos Neoplásicos
- Neoplasias del Sistema Nervioso Central
- Neoplasias del Sistema Nervioso
- Tumores neuroendocrinos
- Nevos y Melanomas
- Metástasis de neoplasias
- Neoplasias Cerebrales
- Melanoma
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Ipilimumab
Otros números de identificación del estudio
- UMCC 2013.114
- HUM00082134 (Otro identificador: University of Michigan)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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