A Phase 2, Multi-Center, Open Label Study to Evaluate Adenoviral p53 (Ad-p53) in Combination With Immune Checkpoint Inhibitor Therapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Tumors Approved for Anti-PD-1 or Anti-PD-L1 Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- The primary efficacy endpoint is objective response rate (ORR)
研究概览
简要总结
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.
详细描述
This is a Phase 2 study of the combination of Ad-p53 administered intra-tumorally in combination with physician's choice of FDA approved immune checkpoint inhibitor therapy in patients with recurrent or metastatic cancers. This is a safety and efficacy study with a single cohort, consisting of the combination of Ad-p53 and infusions of immune checkpoint inhibitors. Immune checkpoint inhibitor treatments will be administered in accordance with FDA package inserts. Comparison will be made to historical data. General safety and preliminary efficacy will be determined using RECIST 1.1, ECOG status and Immune-Related Response Criteria. Biomarker testing of archival or fresh tissue is performed during the study. Enrollment will be up to 40 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ad-p53 with anti-PD-1/anti-PD-L1 100% of patients
Up to 40 patients, all patients treated with intra-tumoral Ad-p53 (dose determined by tumor size) in combination with IV physician's choice of approved immune checkpoint inhibitor
干预措施: Ad-p53 (Drug)
结局指标
主要结局
The primary efficacy endpoint is objective response rate (ORR)
时间窗: Change in tumor size at the end of Cycle 2 (each cycle is 28 days)
Objective response rate will be evaluated by RECIST 1.1
Safety assessments of adverse events per CTCAE
时间窗: Signed Informed Consent through 30 Days following the final treatment
Safety evaluations will tabulate adverse events per CTCAE
次要结局
- Preliminary assessment of Duration of Response (DoR) by RECIST 1.1(Day 1 through end of study, approximately 2 years)
- Preliminary assessment of progression free survival (PFS) by RECIST 1.1(Day 1 through end of study, approximately 2 years)