Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

赞助:

合作者:

信息的提供 (责任方):

Trisha Wise-Draper，University of Cincinnati

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Objective response rate[ Time Frame: 24 months ]

Imaging review using RECIST 1.1

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Adverse events[ Time Frame: 24 months ]
Percentage of adverse events using CTCAE v 5.0
Disease control rate[ Time Frame: 6 months ]
Combined complete response, partial response, and stable disease
Progression-free survival[ Time Frame: 24 months ]
Imaging review using RECIST 1.1
Overall survival[ Time Frame: 24 months ]
Date of on treatment to date of death
Duration of response[ Time Frame: 24 months ]
Date of initial response to progressive disease

描述性信息

简略标题 ^ICMJE

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

正式标题 ^ICMJE

An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

简要概况

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

详细说明

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Durvalumab
One hour infusion
Drug: Cetuximab
Two hour infusion for loading dose followed by weekly one hour infusion

研究工具

Experimental: Durvalumab and Cetuximab
Durvalumab 1500mg IV every 4 weeks Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues for a maximum of 24 months while Cetuximab may continue as maintenance

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2022

预计主要完成日期

October 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Body weight > 30 kg - Histologically or cytologically confirmed recurrent or metastatic HNSCC - Not considered a candidate for other curative therapy (i.e. surgery/RT) - Documented progression of disease after receiving platinum based regimen - ECOG performance status 0-2 Exclusion Criteria: - Nasopharyngeal and salivary gland tumors - Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Trisha Wise-Draper，University of Cincinnati

研究赞助商 ^ICMJE

Trisha Wise-Draper

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Trisha Wise, MD, PhD University of Cincinnati

PRS 账户

University of Cincinnati

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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