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Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

2019年12月19日 更新者：Incyte Corporation

A Randomized, Global, Phase 3 Trial of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Platinum + 5-fluorouracil) Versus the EXTREME Regimen (Cetuximab + Platinum + 5-fluorouracil) in First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) / CheckMate 9NA /ECHO-310

The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).

研究概览

地位

撤销

条件

干预/治疗

研究类型

介入性

阶段

  • 第三阶段

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:

  • Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
  • Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
  • No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
  • Documentation of program death ligand-1 (PD-L1) status prior to randomization.

Exclusion Criteria:

  • Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
  • Untreated central nervous system (CNS) metastases.
  • Carcinomatous meningitis.
  • Active, known or suspected autoimmune disease.
  • Physical and laboratory test findings outside the protocol-defined range.

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
药品：纳武单抗
Nivolumab 每 3 周以方案规定的剂量静脉内给药。
药品：依柏定
Epacadostat 每天两次以方案规定的剂量口服给药。
其他名称：
  • INCB024360
药品：Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
有源比较器：Arm B
EXTREME regimen.
药品：Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
药品：Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.
实验性的：Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
药品：纳武单抗
Nivolumab 每 3 周以方案规定的剂量静脉内给药。
药品：安慰剂
每天两次口服 epacadostat 的匹配安慰剂。
药品：Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
药品：5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

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
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
大体时间：Up to approximately 35 months
Defined as the time between the date of randomization and the date of first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurs first.
Up to approximately 35 months
Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
大体时间：Up to approximately 48 months
Defined as the time between the date of randomization and the date of death.
Up to approximately 48 months

次要结果测量

结果测量
措施说明
大体时间
Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
大体时间：Up to approximately 35 months
Defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.
Up to approximately 35 months
Duration of response (DOR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
大体时间：Up to approximately 35 months
Defined as the time between the date of first documented response (CR or PR per RECIST v1.1) to the date of the first disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Up to approximately 35 months
ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
大体时间：Up to approximately 35 months
Defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.
Up to approximately 35 months
PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
大体时间：Up to approximately 35 months
Defined as the time between the date of randomization and the date of first documented disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Up to approximately 35 months
DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
大体时间：Up to approximately 35 months
Defined as the time between the date of first documented response (CR or PR per RECIST v1.1) to the date of the first disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Up to approximately 35 months
Time to meaningful symptomatic deterioration (TTSD) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
大体时间：Up to approximately 60 months
TTSD assessed by the 10-item Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) Symptom Index (FHNSI-10).
Up to approximately 60 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

Incyte Corporation

合作者

Bristol-Myers Squibb

调查人员

  • 研究主任：Vinny Hayreh, MD、Bristol-Myers Squibb Research and Development

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)

2017年12月15日

初级完成 (实际的)

2018年4月20日

研究完成 (实际的)

2018年4月20日

研究注册日期

首次提交

2017年11月9日

首先提交符合 QC 标准的

2017年11月9日

首次发布 (实际的)

2017年11月14日

研究记录更新

最后更新发布 (实际的)

2019年12月20日

上次提交的符合 QC 标准的更新

2019年12月19日

最后验证

2019年12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

  • CA2099NA/ECHO-310

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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