- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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 novembro de 2019 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
12
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Gent, Bélgica, 9000
- AZ Maria Middelares
-
-
-
-
-
Barcelona, Espanha, 08028
- Hosp. Univ. Quiron Dexeus
-
Elche, Espanha, 03203
- Hosp. Gral. Univ. de Elche
-
Jaén, Espanha, 23007
- Complejo Hospitalario de Jaén
-
Málaga, Espanha, 29010
- Hosp. Regional Univ. de Malaga
-
Palma de Mallorca, Espanha, 07198
- Hosp. Son Llatzer
-
Valencia, Espanha, 46015
- Hosp. Arnau de Vilanova de Valencia
-
-
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37201
- Tennessee Oncology, PLLC
-
-
Washington
-
Spokane, Washington, Estados Unidos, 99208-1129
- Medical Oncology Associates, PS
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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.
|
Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
Outros nomes:
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
|
Comparador Ativo: 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.
|
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Phase 1b: Percentage of Participants With Objective Response
Prazo: Up to 6.8 Months
|
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.
|
Up to 6.8 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Phase 1b: Duration of Objective Response (DOR)
Prazo: Up to 6.8 months
|
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.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)
Prazo: Up to 6.8 months
|
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.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)
Prazo: Up to 6.8 months
|
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.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Prazo: Up to 6.8 months
|
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.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Positive Blood Culture
Prazo: Up to 6.8 months
|
Number of participants with surveillance cultures positive for listeriosis were reported.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Bacterial Shedding
Prazo: Up to 6.8 months
|
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.
|
Up to 6.8 months
|
Phase 1b: Serum Concentrations of Nivolumab
Prazo: Up to 6.8 months
|
Nivolumab serum concentrations were reported.
|
Up to 6.8 months
|
Phase 1b: Number of Participants With Anti-nivolumab Antibodies
Prazo: Up to 6.8 months
|
Number of participants with antibodies to nivolumab were reported.
|
Up to 6.8 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de janeiro de 2018
Conclusão Primária (Real)
9 de outubro de 2018
Conclusão do estudo (Real)
9 de outubro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de dezembro de 2017
Primeira postagem (Real)
13 de dezembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de dezembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de novembro de 2019
Última verificação
1 de novembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Adenocarcinoma
- Adenocarcinoma de Pulmão
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de Ponto de Verificação Imunológica
- Nivolumabe
Outros números de identificação do estudo
- CR108232
- 2016-002543-41 (Número EudraCT)
- 64041757LUC2002 (Outro identificador: Janssen Research & Development, LLC)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Adenocarcinoma de Pulmão
-
Aalborg UniversityConcluídoUltrassonografia Point of Care (POCUS)Dinamarca
-
Sorbonne UniversityAalborg UniversityRecrutamentoUltrassom Point of CareFrança
-
Asociacion Española Primera en SaludIntensive Care Unit Pasteur HospitalConcluídoUltrassom Point of CareUruguai
-
Aga Khan UniversityThe Hospital for Sick Children; Grand Challenges CanadaDesconhecidoUltrassom Point of CarePaquistão
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...ConcluídoTransgênero, HIV Continuum of CareEstados Unidos
-
Thomas Jefferson UniversityRecrutamentoVentilação mecânica | Ultrassom Point of Care | Oxigenação | Ventilação Manual | Distúrbio da função cardíaca pós-operatórioEstados Unidos
-
Hospital for Special Surgery, New YorkRecrutamentoPeptídeo 1 semelhante ao glucagon | Ultrassom Gástrico | Ultrassom Point of CareEstados Unidos, Canadá
-
Queens College, The City University of New YorkRecrutamentoPublicação de artigos submetidos ao American Journal of Public HealthEstados Unidos
-
Tanta UniversityDesconhecidoDiâmetro da bainha do nervo óptico | Ultrassom Point of CareEgito
-
Johann Wolfgang Goethe University HospitalConcluídoFormação de Coágulos e Agregação de Plaquetas em Testes Point of CareAlemanha
Ensaios clínicos em JNJ-64041757
-
Janssen Research & Development, LLCRescindidoCarcinoma pulmonar de células não pequenasEstados Unidos
-
Janssen Research & Development, LLCRecrutamentoLinfoma Não-HodgkinDinamarca, Israel, Espanha, Austrália
-
Janssen Research & Development, LLCConcluído
-
Janssen Research & Development, LLCConcluído
-
Janssen Research & Development, LLCConcluído
-
Janssen-Cilag International NVConcluído
-
Janssen Research & Development, LLCConcluído
-
Janssen Research & Development, LLCConcluído
-
Janssen Research & Development, LLCConcluído
-
Janssen Research & Development, LLCAtivo, não recrutandoLinfoma Não-Hodgkin | Leucemia linfocítica crônicaEstados Unidos, Israel, Republica da Coréia, Holanda, Bélgica, Espanha, Austrália, Polônia, França, Geórgia, Moldávia, República da, Ucrânia