MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
14 de septiembre de 2016 actualizado por: EMD Serono
A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab
This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Rockland, Massachusetts, Estados Unidos
- Please Contact U.S. Medical Information
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment
Subjects need to have
- one lesion that can be irradiated
- at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
- one lesion that can be biopsied before treatment with SBRT and MSB0010445
- one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445
- The lesion that is biopsied at Baseline can be the lesion that will be irradiated
- The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline
- Signed written informed consent
- Male and female subjects at least 18 years of age
- Life expectancy greater than or equal to (>=) 4 months
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Active central nervous system metastasis
- Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
- Pre-existing pericardial effusion or history of Grade >=2 pleural effusion or ascites within 3 months before first dose of SBRT
- Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
- Other protocol defined exclusion criteria could apply
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
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Experimental: MSB0010445 Low Dose Cohort 0.3 mg/kg
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MSB0010445 will be administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion.
SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
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Experimental: MSB0010445 Intermediate Dose Cohort 1.0 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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Experimental: MSB0010445 High Dose Cohort 1.8 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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Experimental: MSB0010445 High Dose Cohort 2.4 mg/kg
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SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy).
If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
MSB0010445 will be administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)
Periodo de tiempo: Baseline up to Day 21
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DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.
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Baseline up to Day 21
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Periodo de tiempo: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment.
For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
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Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs
Periodo de tiempo: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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TEAE was defined as an AE that started on or after the first administration of SBRT.
An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
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Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2014
Finalización primaria (Actual)
1 de abril de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
25 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
25 de octubre de 2013
Publicado por primera vez (Estimar)
31 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2016
Última verificación
1 de septiembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EMR 062235-005
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. .
Ensayos clínicos sobre MSB0010445 (0.3 milligram per kilogram [mg/kg])
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Sichuan Haisco Pharmaceutical Group Co., LtdTerminado