- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03371381
An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung
23 de noviembre de 2019 actualizado por: Janssen Research & Development, LLC
An Open-Label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung
The purpose of this study is to evaluate whether the efficacy of JNJ-757 combined with nivolumab is better than the efficacy of nivolumab monotherapy for participants with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung.
The open-label study comprises of two parts i.e.
Phase 1b (safety run-in) and Phase 2. Phase1b consists of 1 arm whereas Phase 2 is randomized into 2 groups i.e.
Group A and Group B.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study evaluates safety and efficacy of JNJ-64041757 with nivolumab.
The total study duration will be up to 3 years.
It will consist of safety run-in and randomized phase which will comprise of Screening phase(Day(D) -28 to D -1),Treatment Phase,End of Adverse Event Evaluation Period (100 D after last dose of nivolumab)and Post-treatment Follow-up Phase(Every 3 Months).
The primary hypothesis is that addition of JNJ-640417577 to nivolumab will result in higher objective response rate compared with nivolumab monotherapy in at least one of programmed death receptor ligand 1 subgroups in participants with relapsed or refractory StageIIIB or StageIV adenocarcinoma of lung.
The study procedures include blood culture bacterial shedding assessments, pharmacokinetics, immunogenicity, and biomarkers.
Safety will be monitored throughout study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- Fase 2
- Fase 1
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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Gent, Bélgica, 9000
- AZ Maria Middelares
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Barcelona, España, 08028
- Hosp. Univ. Quiron Dexeus
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Elche, España, 03203
- Hosp. Gral. Univ. de Elche
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Jaén, España, 23007
- Complejo Hospitalario de Jaén
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Málaga, España, 29010
- Hosp. Regional Univ. de Malaga
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Palma de Mallorca, España, 07198
- Hosp. Son Llatzer
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Valencia, España, 46015
- Hosp. Arnau de Vilanova de Valencia
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37201
- Tennessee Oncology, PLLC
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Washington
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Spokane, Washington, Estados Unidos, 99208-1129
- Medical Oncology Associates, PS
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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:
- Disease-related criteria: Histologically documented adenocarcinoma of the lung; Stage IIIB or Stage IV disease; Biopsy material available for central assessment of programmed death receptor ligand 1 (PD-L1) and mesothelin
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Progressive disease during or after platinum-based doublet chemotherapy
- A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days before the first dose of nivolumab
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- Tumor with activating epidermal growth factor receptor (EGFR) mutation or ALK translocation
- More than 1 prior line of chemotherapy for metastatic disease (Phase 2)
- History of disallowed therapies, as follows: In Phase 1b only: Prior exposure to anti-programmed death receptor-1(PD1), anti programmed death receptor ligand 1 (PD-L1), anti-programmed death receptor ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody within 28 days before the first dose of study agent, In Phase 2 only: Prior exposure to anti-PD1, anti PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody, History of listeriosis or vaccination with a Listeria-based vaccine or prophylactic vaccine within 28 days before the first dose of study agent, Chemotherapy within 28 days before the first dose of study agent, Radiation within 14 days before the first dose of study agent
- History of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNF alpha) therapies or other immunosuppressant medications during the study
- Active second malignancy within 2 years prior to Cycle 1 Day 1 (Phase 1b) or randomization (Phase 2)
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: Nivolumab + JNJ-64041757
Phase 1b and Phase 2 Group A/Arm 1: Participants will receive separate intravenous (IV) infusions of nivolumab and JNJ-64041757 over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
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Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
Otros nombres:
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
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Comparador activo: Nivolumab
Phase 2 Group B/Arm 2: Participants will receive intravenous (IV) infusions of nivolumab over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
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Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Phase 1b: Percentage of Participants With Objective Response
Periodo de tiempo: Up to 6.8 Months
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Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
RECIST for CR - disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
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Up to 6.8 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Phase 1b: Duration of Objective Response (DOR)
Periodo de tiempo: Up to 6.8 months
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Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause.
RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum).
Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR).
Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease.
Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.
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Up to 6.8 months
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Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)
Periodo de tiempo: Up to 6.8 months
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Number of participants with PFS event (progressed or died before progression) were reported.
PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first.
RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum).
Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR).
Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease.
Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.
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Up to 6.8 months
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Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)
Periodo de tiempo: Up to 6.8 months
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Number of participants with OS event (died) were reported.
Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause.
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Up to 6.8 months
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Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to 6.8 months
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment.
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Up to 6.8 months
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Phase 1b: Number of Participants With Positive Blood Culture
Periodo de tiempo: Up to 6.8 months
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Number of participants with surveillance cultures positive for listeriosis were reported.
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Up to 6.8 months
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Phase 1b: Number of Participants With Bacterial Shedding
Periodo de tiempo: Up to 6.8 months
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Number of participants with bacterial shedding were reported.
The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva.
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Up to 6.8 months
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Phase 1b: Serum Concentrations of Nivolumab
Periodo de tiempo: Up to 6.8 months
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Nivolumab serum concentrations were reported.
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Up to 6.8 months
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Phase 1b: Number of Participants With Anti-nivolumab Antibodies
Periodo de tiempo: Up to 6.8 months
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Number of participants with antibodies to nivolumab were reported.
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Up to 6.8 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
2 de enero de 2018
Finalización primaria (Actual)
9 de octubre de 2018
Finalización del estudio (Actual)
9 de octubre de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
11 de diciembre de 2017
Publicado por primera vez (Actual)
13 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de diciembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
23 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Adenocarcinoma
- Adenocarcinoma de pulmón
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Nivolumab
Otros números de identificación del estudio
- CR108232
- 2016-002543-41 (Número EudraCT)
- 64041757LUC2002 (Otro identificador: Janssen Research & Development, LLC)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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