A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 73
- 主要终点
- Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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
- None
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
- •Measurable disease based on RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function per protocol-defined criteria.
- •Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
- •Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.
排除标准
- •Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
- •Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- •Use of protocol-defined prior/concomitant therapy.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Active autoimmune disease that has required systemic treatment in past 2 years.
- •Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
- •Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).
研究组 & 干预措施
Pembrolizumab + Epacadostat
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Epacadostat
干预措施: Epacadostat (Drug)
Pembrolizumab
干预措施: Pembrolizumab (Drug)
EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
干预措施: Cetuximab (Drug)
EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
干预措施: Cisplatin (Drug)
EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
干预措施: Carboplatin (Drug)
EXTREME
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
时间窗: Minimum Week 9
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans.
次要结局
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)(Up to 14 months)
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs(Up to 14 months)