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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 actualizado 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).

Descripción general del estudio

Estado

Suspendido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

375

Fase

  • Fase 3

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

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

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 a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Droga: 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.
Otros nombres:
  • Terepril monoclonal antibody
Droga: 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.
Otros nombres:
  • Paclitaxel For Injection（Albumin Bound）
Comparador de placebos: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Droga: 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.
Otros nombres:
  • Paclitaxel For Injection（Albumin Bound）
Droga: Placebo
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigadores

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

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)

21 de diciembre de 2018

Finalización primaria (Anticipado)

30 de diciembre de 2019

Finalización del estudio (Anticipado)

30 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

12 de diciembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

13 de diciembre de 2018

Publicado por primera vez (Actual)

17 de diciembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2019

Última verificación

1 de diciembre de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NABP201801

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los 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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