NCT02307149已完成1 期
A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)
Viralytics11 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年5月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Response
研究概览
简要总结
Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.
详细描述
Primary Objective:
To evaluate the safety and efficacy of CAVATAK (CVA21) administered intratumorally in combination with the approved dose and schedule of ipilimumab. Of particular interest is to estimate the overall response rate (ORR) in the subgroup of subjects with unresectable or metastatic stage III B/C or IV melanoma who have progressed on a single prior anti-PD-1 therapy.
Secondary Objectives:
- Assess the clinical efficacy of ipilimumab in combination with intratumoral CVA21 in terms of:
- Immune-related progression-free survival (irPFS) at 6 and 12 months,
- Durable response rate (DRR),
- 1-year survival,
- Overall survival (OS), and
- Quality of life.
- Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab.
- Assess the time to initial response.
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
- •Patients with unresectable or metastatic stage III B/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on prior anti-PD-1 therapy, according to RECIST 1.1 criteria. Patients who progressed within 3 months of treatment start are excluded.
- •Patients must have at least one cutaneous or subcutaneous tumor, measuring 0.5 to 5.0 cm in the longest diameter, or a palpable lymph node. At least one tumor must qualify as an index lesion that can be accurately and reproducibly measured in two dimensions for which the longest diameter is .10 mm (.15 mm in short axis diameter [SAD] for lymph nodes), and be amenable to intratumoral injection.
- •Histological confirmation of melanoma will be required by previous biopsy or cytology.
- •Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
- •Patients with ≤ 3 visceral metastases (excluding pulmonary lesions), with no lesions >3.0 cm. Patients with substantial tumor burden of non-measurable disease may not be good candidates for an immunotherapy and should be discussed with the Medical Monitor.
- •ECOG performance status of 0-
排除标准
- •Patients with tumors to be injected lying close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigator, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. Patients with lesions in mucosal areas (vulvar, anus, oral cavity, etc.), are eligible, as long as the subject has at least one lesion suitable for injection; consult Medical Monitor for confirmation.
- •Patients with active, known or suspected autoimmune disease except for autoimmune thyroiditis or vitiligo. Thyroiditis patients must be asymptomatic, on adequate thyroid replacement and have normal thyroid function tests.
- •Patients with active colitis or immune-mediated colitis that has not resolved to grade 1 or less.
- •Patients with untreated brain metastases. Patients with treated brain metastases who are off corticosteroids for at least two weeks and who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
- •Patients previously treated with CVA21.
研究组 & 干预措施
CAVATAK and ipilimumab
Experimental
CAVATAK intratumoral injection up to a total dose of 3 x 10⁸ TCID50 and ipilimumab intravenously at the recommended dose of 3 mg/kg
干预措施: CAVATAK (Biological)
CAVATAK and ipilimumab
Experimental
CAVATAK intratumoral injection up to a total dose of 3 x 10⁸ TCID50 and ipilimumab intravenously at the recommended dose of 3 mg/kg
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Response
时间窗: 106 days
Best response of complete response (CR) or partial response (PR)
次要结局
- OS(Through study completion, an average of 2 years)
- PFS(At 6 and 12 months)
- DRR(lasting 26 weeks or longer)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)MelanomaNCT02565992Viralytics36
已完成
1 期
CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER)Uveal MelanomaLiver MetastasesNCT03408587Viralytics11
Unknown
1 期
Pembrolizumab + CVA21 in Advanced NSCLCNon-Small Cell Lung CancerNCT02824965Olivia Newton-John Cancer Research Institute11
Unknown
1 期
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACCMelanoma (Skin)Squamous Cell Carcinoma of the SkinCarcinoma, Squamous Cell of Head and NeckCarcinoma, Adenoid CysticNCT03291002CureVac98
已完成
1 期
Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)Breast CancerProstate CancerMelanomaNCT00636558Viralytics8