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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

2019年11月23日 更新者：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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

12

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 比利时
      • Gent、比利时、9000
        • AZ Maria Middelares
  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21287
        • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
    • Tennessee
      • Nashville、Tennessee、美国、37201
        • Tennessee Oncology, PLLC
    • Washington
      • Spokane、Washington、美国、99208-1129
        • Medical Oncology Associates, PS
  • 西班牙
      • Barcelona、西班牙、08028
        • Hosp. Univ. Quiron Dexeus
      • Elche、西班牙、03203
        • Hosp. Gral. Univ. de Elche
      • Jaén、西班牙、23007
        • Complejo Hospitalario de Jaén
      • Málaga、西班牙、29010
        • Hosp. Regional Univ. de Malaga
      • Palma de Mallorca、西班牙、07198
        • Hosp. Son Llatzer
      • Valencia、西班牙、46015
        • Hosp. Arnau de Vilanova de Valencia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
生物：JNJ-64041757
Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
其他名称：
  • JNJ-757
药品：Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
有源比较器：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.
药品：Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1b: Percentage of Participants With Objective Response
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Phase 1b: Duration of Objective Response (DOR)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：Up to 6.8 months
Nivolumab serum concentrations were reported.
Up to 6.8 months
Phase 1b: Number of Participants With Anti-nivolumab Antibodies
大体时间：Up to 6.8 months
Number of participants with antibodies to nivolumab were reported.
Up to 6.8 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月2日

初级完成 (实际的)

2018年10月9日

研究完成 (实际的)

2018年10月9日

研究注册日期

首次提交

2017年11月30日

首先提交符合 QC 标准的

2017年12月11日

首次发布 (实际的)

2017年12月13日

研究记录更新

最后更新发布 (实际的)

2019年12月11日

上次提交的符合 QC 标准的更新

2019年11月23日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CR108232
  • 2016-002543-41 (EudraCT编号)
  • 64041757LUC2002 (其他标识符：Janssen Research & Development, LLC)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

肺腺癌的临床试验

JNJ-64041757的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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