CTIS2024-512015-47-00进行中（未招募）1 期
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) - MK-3475-669
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Incyte Corp.
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants with histologically or cytologically-confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx., Measurable disease based on RECIST v1.1., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., 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 Head and Neck Squamous Cell Carcinoma (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).
研究者
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