NCT04408898撤回2 期
A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Adaptimmune
- 试验地点
- 8
- 主要终点
- Efficacy: Overall Response Rate (ORR)
研究概览
简要总结
This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <75 years
- •Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology.
- •Checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). May have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy.
- •Subjects that have already received pembrolizumab (alone or in combination) and are progressing or have completed immune checkpoint inhibitor therapy for recurrent/metastatic disease, may still be enrolled and will skip Part A of the study.
- •These subjects will enroll into Part B when manufactured T cells are available.
- •Measurable disease according to RECIST v1.
- •HLA-A*02 positive by central laboratory.
- •Tumor shows MAGE-A4 expression confirmed by central laboratory.
- •ECOG Performance Status of 0 or
- •Left ventricular ejection fraction (LVEF) ≥50%.
- •Note: other protocol defined Inclusion criteria may apply
排除标准
- •Positive for any HLA-A*02 allele other than: one of the inclusion alleles, HLA- A*02:07P or HLA-A*02 null alleles
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody.
- •History of autoimmune or immune mediated disease
- •Leptomeningeal disease, carcinomatous meningitis or CNS metastases.
- •Other prior malignancy that is not considered by the Investigator to be in complete remission
- •Clinically significant cardiovascular disease
- •Uncontrolled intercurrent illness
- •Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
- •Pregnant or breastfeeding
- •Note: other protocol defined Exclusion criteria may apply.
研究组 & 干预措施
ADP-A2M4 T cells in combination with pembrolizumab
Experimental
干预措施: ADP-A2M4 in combination with pembrolizumab. (Genetic)
结局指标
主要结局
Efficacy: Overall Response Rate (ORR)
时间窗: 2.5 years
ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
次要结局
- Time to response (TTR)(2.5 years)
- Duration of response (DoR)(2.5 years)
- Duration of stable disease (DoSD)(2.5 years)
- Progression- free survival (PFS)(2.5 years)
- Overall survival (OS)(2.5 years)
- Best overall response (BOR)(2.5 years)
- To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs)(2.5 years)
- To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest(2.5 years)
- To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells(15 years)
研究者
研究点 (8)
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