A Phase 1, Dose-finding and Signal-seeking Study of the Safety & Efficacy of Intravenous CAVATAK® Alone and in Combination With Pembrolizumab in Patients With Late Stage Solid Tumours (VLA-009 STORM / KEYNOTE-200)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 35
- 主要终点
- Response rate assessed according to immune-related RECIST 1.1 criteria
研究概览
简要总结
The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while sparing normal cells) and to establish a safe multi-dose schedule of the virus for the treatment of solid tumors where enhanced expression of ICAM-1 and/ or DAF receptor occurs.
This trial consists of 2 sequential parts: VLA-009 (Part A) conducted only in the UK and employed CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and bladder cancer. VLA-009 (Part B) conducted in the US, AUS and UK employs CVA21 with pembrolizumab in NSCLC and bladder cancer.
Both VLA-009A and VLA-009B are open-label, multi-center, ascending dose escalation (3+3 design) dose-finding and signal-seeking studies.
Part A of the study is now complete and closed to enrolment. Part B is currently enrolling.
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
- •Histologically-confirmed (1) NSCLC, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3C or stage 4 melanoma.
- •VLA009A: Locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible and judged not to be a candidate for the current standard of care treatment. VLA009B: locally advanced and/or metastatic disease and judged to be a candidate for pembrolizumab to be used in combination with CVA
- •All subjects in Cohort 3 or Phase 2 dose (P2D) must have a lesion accessible for FNA or core or open biopsy on day 8 of the first treatment cycle.
- •No CVA21 neutralising antibody (≤ 1:16)
- •Measurable or evaluable disease
排除标准
- •Second primary malignancy within the past 2 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer)
- •Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour
结局指标
主要结局
Response rate assessed according to immune-related RECIST 1.1 criteria
时间窗: Up to 6 months
次要结局
未报告次要终点