Completado
Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)
Qué se está evaluando
Pembrolizumab
+ Pembrolizumab
+ Carboplatin
BiológicoMedicamento
Quiénes están siendo reclutados
Neoplasias+5
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
A partir de 18 años
+20 Criterios de eligibilidad
Cómo está diseñado el estudio
Estudio de Tratamiento
Fase 2
Intervencional
Inicio del estudio: noviembre de 2012
Resumen
Patrocinador PrincipalMerck Sharp & Dohme LLC
Última actualización: 18 de mayo de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 20 de noviembre de 2012
Fecha en la que se inscribió al primer participante.Two interim and one final statistical analyses were planned for and conducted during this study: Interim Analysis 1 (futility analysis), Interim Analysis 2 (~18 months into study): database cutoff date 12-May-2014, and Final Analysis (~36 months into study): database cutoff date 16-Nov-2015. The End of Trial Analysis for the study was conducted at ~75 months into the study: database cutoff date 31-Jan-2019.
Patrocinador PrincipalMerck Sharp & Dohme LLC
Última actualización: 18 de mayo de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Detalles del Diseño
Se reclutarán 540 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Condiciones
Criterios
Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
NeoplasiasNeoplasias por tipo histológicoNeoplasias por SitioNeoplasias de Células Germinales y EmbrionariasNeoplasias del Tejido NerviosoEnfermedades de la PielNeoplasias de la pielMelanoma
Criterios
6 criterios de inclusión requeridos para participar
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting)
Participants must be refractory to ipilimumab
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14 criterios de exclusión impiden participar
Active Hepatitis B or Hepatitis C
Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Active infection requiring systemic therapy
Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier
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Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Grupos de Tratamiento
Objetivos del Estudio
5 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalParticipants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
Grupo II
ExperimentalParticipants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
Grupo III
Comparador ActivoParticipants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice.
(Up to ~66 months)
Grupo IV
ExperimentalParticipants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
Grupo 5
ExperimentalParticipants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio no tiene datos de ubicaciónNo hay información disponible sobre las ubicaciones de este estudio.
CompletadoNingun centro de estudio