NCT02454179已完成2 期
A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Response
研究概览
简要总结
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.
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
- •Men and women ≥ 18 years of age
- •Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
- •Presence of radiographically measurable disease as defined by RECIST 1.1
- •ECOG performance status of 0 or 1
排除标准
- •Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
- •Known central nervous system metastases and/or carcinomatous meningitis
- •A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
- •Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
研究组 & 干预措施
Arm 1
Experimental
pembrolizumab
干预措施: pembrolizumab (Drug)
Arm 2
Experimental
acalabrutinib in combination with pembrolizumab
干预措施: pembrolizumab (Drug)
Arm 2
Experimental
acalabrutinib in combination with pembrolizumab
干预措施: Acalabrutinib (Drug)
结局指标
主要结局
Number of Participants With Overall Response
时间窗: 52 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT02448303Acerta Pharma BV74
已完成
1 期
Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLLSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaProlymphocytic LeukemiaNCT02296918Acerta Pharma BV69
已完成
2 期
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)Ovarian CancerNCT02537444Acerta Pharma BV78
进行中（未招募）
2 期
Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell CancerMetastatic Head and Neck CarcinomaParanasal Sinus Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7Unresectable Head and Neck Squamous Cell CarcinomaNCT03468218Emory University36
进行中（未招募）
2 期
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib TherapyChronic Lymphocytic LeukemiaNCT02717611Acerta Pharma BV60