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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 to
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.
- •Documentation of program death ligand-1 (PD-L1) status prior to randomization.
排除标准
- •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.
研究组 & 干预措施
Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Nivolumab (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Epacadostat (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Carboplatin (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Cisplatin (Drug)
Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: 5-Fluorouracil (Drug)
Arm B
EXTREME regimen.
干预措施: Carboplatin (Drug)
Arm B
EXTREME regimen.
干预措施: Cisplatin (Drug)
Arm B
EXTREME regimen.
干预措施: Cetuximab (Drug)
Arm B
EXTREME regimen.
干预措施: 5-Fluorouracil (Drug)
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Nivolumab (Drug)
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Placebo (Drug)
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Carboplatin (Drug)
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: Cisplatin (Drug)
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
时间窗: Up to approximately 48 months
Defined as the time between the date of randomization and the date of death.
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
时间窗: 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.
次要结局
- PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)(Up to approximately 35 months)
- DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)(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)(Up to approximately 60 months)
- Duration of response (DOR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)(Up to approximately 35 months)
- Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)(Up to approximately 35 months)
- ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)(Up to approximately 35 months)