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A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC

6 de agosto de 2019 atualizado por: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Visão geral do estudo

Status

Suspenso

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

375

Estágio

  • Fase 3

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

  • China
      • Beijing, China
        • The Fifth Medical Center of PLA General Hospital

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 a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  1. Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
  2. No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
  3. Eligible for taxane monotherapy；
  4. Eastern Cooperative Oncology Group performance status of 0 or 1；
  5. Measurable disease as defined by RECIST v1.1；
  6. Adequate hematologic and end-organ function。

Exclusion Criteria:

  1. Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
  2. History of autoimmune disease；
  3. History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
  4. Prior allogeneic stem cell or solid organ transplantation;
  5. Active hepatitis B or hepatitis C;
  6. Positive of HIV antibody.

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Medicamento: JS001，an engineered anti-PD-1 antibody
JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Outros nomes:
  • Terepril monoclonal antibody
Medicamento: Nab-Paclitaxel
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
Outros nomes:
  • Paclitaxel For Injection（Albumin Bound）
Comparador de Placebo: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Medicamento: Nab-Paclitaxel
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
Outros nomes:
  • Paclitaxel For Injection（Albumin Bound）
Medicamento: Placebo
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
Prazo: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
Prazo: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Prazo: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Prazo: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Prazo: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Overall Survival (OS)
Prazo: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
OS is defined as the time from randomization to death from any cause.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
OS rate at 12 months
Prazo: the percent of participants that are alive at 12months from Day 1.
OS is defined as the time from randomization to death from any cause.
the percent of participants that are alive at 12months from Day 1.
OS rate at 24 months
Prazo: the percent of participants that are alive at 24 months from Day 1.
OS is defined as the time from randomization to death from any cause.
the percent of participants that are alive at 24 months from Day 1.
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Prazo: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Prazo: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Prazo: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Prazo: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Percentage and severity of Participants With Adverse Events (AEs)
Prazo: From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
percentage and CTC AE(v5.0) of AEs
From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
Percentage of Participants With Anti-Drug Antibodies (ATAs)
Prazo: Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigadores

  • Investigador principal: JIANG ZE FEI, PHD, Beijing 302 Hospital

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)

21 de dezembro de 2018

Conclusão Primária (Antecipado)

30 de dezembro de 2019

Conclusão do estudo (Antecipado)

30 de julho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

12 de dezembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de dezembro de 2018

Primeira postagem (Real)

17 de dezembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2019

Última verificação

1 de dezembro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NABP201801

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado 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 .

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