Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0.
研究概览
简要总结
This study will employ a phase Ib design using the established dose of CAVATAK with pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be important in amplifying the T-cell potentiating effects of pembrolizumab.
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
- •Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
- •At least one tumor must qualify to be an index lesion for modified WHO criteria.
- •Subjects must have adequate hematologic, hepatic and renal function.
- •ECOG performance status of 0 or
- •Anticipated lifespan greater than 12 weeks
排除标准
- •Ocular primary tumors.
- •Presence of any central nervous system tumor that has not been stable for at least 4 weeks off corticosteroids.
- •Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
- •Subjects with active, known or suspected autoimmune or immunosuppressive disease.
- •Subjects previously treated with CVA
- •Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment.
- •Subject has received chemotherapy within the last 4 weeks prior to first treatment.
- •Clinically significant cardiovascular disease.
- •Females of childbearing potential must have negative serum or urine pregnancy test.
- •Subjects requiring or using other investigational agents while on treatment in this trial.
- •History of other malignancy within the last 3 years (with exceptions).
- •Active infection requiring systemic therapy.
- •Known history of HIV disease, active hepatitis B or hepatitis C.
- •History or evidence of other clinically significant disorders that would pose a risk to subject safety.
- •Inability to give informed consent and comply with the protocol.
研究组 & 干预措施
CAVATAK and pembrolizumab
Intratumoral CAVATAK administration on trial days 1, 3, 5 and 8 and at 3-weekly intervals up to a maximum of 19 total with intravenous pembrolizumab (2 mg/kg solution) starting on day 8 and continuing every 3 weeks, up to 2 years.
干预措施: CAVATAK (Biological)
CAVATAK and pembrolizumab
Intratumoral CAVATAK administration on trial days 1, 3, 5 and 8 and at 3-weekly intervals up to a maximum of 19 total with intravenous pembrolizumab (2 mg/kg solution) starting on day 8 and continuing every 3 weeks, up to 2 years.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0.
时间窗: Up to 2 years
次要结局
未报告次要终点