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MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)

2019年2月26日 更新者：MedImmune LLC

A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination With Tremelimumab or AZD9150 in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736 (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a multicenter, open-label, dose-escalation and dose-expansion study of MEDI4736 (durvalumab) as monotherapy or in combination with either tremelimumab or AZD9150. The objectives are to describe any dose-limiting toxicities, determine the maximum tolerated dose, and evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of MEDI4736 as monotherapy or in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

研究类型

介入性

注册 (实际的)

32

阶段

  • 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

  • 法国
      • Marseille、法国、13273
        • Research Site
      • Villejuif、法国、94805
        • Research Site
  • 爱尔兰
      • Dublin 8、爱尔兰
        • Research Site
      • Galway、爱尔兰
        • Research Site
  • 美国
    • California
      • La Jolla、California、美国、92093
        • Research Site
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Research Site
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
        • Research Site
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Research Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Research Site
    • Texas
      • Dallas、Texas、美国、75390
        • Research Site
      • Houston、Texas、美国、77030
        • Research Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Research Site
  • 英国
      • Leicester、英国、LE1 5WW
        • Research Site

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:

  1. Age ≥ 18 years
  2. Subjects with histologically confirmed relapsed or refractory DLBCL who have received at least 1 prior rituximab containing chemotherapy regimen but no more than 5 prior lines of therapy
  3. Eastern Cooperative Group (ECOG) performance status of 0 or 1
  4. Measurable disease by International Working Group (IWG) response criteria for lymphoma
  5. Adequate organ and marrow function

Exclusion Criteria:

  1. Previous immune-mediated therapy
  2. Subjects with prior ASCT or allogenic HCT. Subjects ineligible for available curative options after failing ASCT and have met the hematologic criteria are eligible to participate in this study. Subjects with prior allogenic HCT will be excluded.
  3. Documented current central nervous system involvement

3. Active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. Concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)

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：MEDI4736
药品：MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
实验性的：MEDI4736 and tremelimumab
药品：MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
药品：tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
实验性的：MEDI4736 and AZD9150
药品：MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
药品：AZD9150
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

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
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
大体时间：Screening through 90 days after the last dose of study medication
Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
大体时间：First dose of study medications through 28 days after the administration of MEDI4736 or MEDI4736 and tremelimumab, 35 days after administration of MEDI4736 and AZD9150
Changes from baseline in laboratory parameters, vital signs, and ECGs
First dose of study medications through 28 days after the administration of MEDI4736 or MEDI4736 and tremelimumab, 35 days after administration of MEDI4736 and AZD9150

次要结果测量

结果测量
大体时间
Number of subjects who develop anti-drug antibodies (ADA)
大体时间：Screening through 90 days after last dose of study medication
Screening through 90 days after last dose of study medication
Time to Response
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Duration of Response
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Progression Free survival
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Time to progression
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Event free survival
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
Overall survival
大体时间：Screening though 3 years after the last subject receives the first dose of study medication
Screening though 3 years after the last subject receives the first dose of study medication
MEDI4736 Maximum Plasma Concentration (Cmax)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Maximum Plasma Concentration (Cmax)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
AZD9150 Maximum Plasma Concentration (Cmax)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
MEDI4736 Minimum Plasma Concentration (Cmin)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Minimum Plasma Concentration (Cmin)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
AZD9150 Minimum Plasma Concentration (Cmin)
大体时间：Measured at defined study visits from time of first dose through end of treatment
Measured at defined study visits from time of first dose through end of treatment
Individual MEDI4736 Concentrations
大体时间：Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual tremelimumab Concentrations
大体时间：Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual AZD9150 Concentrations
大体时间：Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Change from baseline of STAT3 RNA (signal transducer and activator of transcription)
大体时间：Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
Baseline PD-L1 protein expression within the tumor
大体时间：Measured on tumor samples provided at screening
Measured on tumor samples provided at screening

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

MedImmune 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)

2016年7月13日

初级完成 (实际的)

2019年2月4日

研究完成 (实际的)

2019年2月4日

研究注册日期

首次提交

2015年8月27日

首先提交符合 QC 标准的

2015年9月11日

首次发布 (估计)

2015年9月15日

研究记录更新

最后更新发布 (实际的)

2019年2月27日

上次提交的符合 QC 标准的更新

2019年2月26日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D4190C00023

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.

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条件

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地点

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