NCT03802604已完成早期 1 期
Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
SOLTI Breast Cancer Research Group4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年12月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Rate of residual cancer burden class 0 and 1 (RCB0/1)
研究概览
简要总结
PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.
详细描述
Primary objective:
• To evaluate the efficacy (as measured by residual cancer burden [RCB] class 0/1 rate) of Talimogene Laherparepvec with Atezolizumab given to subjects with operable early breast cancer who present residual disease after neoadjuvant chemotherapy (NAC).
Secondary objectives include:
- To assess the rate of pathological complete response (pCR) in the breast (pCRB) and breast and axilla (pCRBL) at definitive surgery after neoadjuvant treatment with T-VEC and atezolizumab.
- To determine the clinical and radiological ORR of breast tumors to TVEC- atezolizumab given in the neoadjuvant setting.
- To assess RCB index in continuous variable and by the 4 RCB class (RCB0, RCB1, RCB2 and RCB 3) after treatment with T-VEC and atezolizumab.
- Comparing the expression of a gene signature tracking activated CD8 T-cells at surgery after treatment with T-VEC and atezolizumab with residual disease after NAC.
- To evaluate the safety of T-VEC in combination with atezolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events.
- Translational and exploratory objectives are included.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 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
Talimogene laherparepvec + Atezolizumab
Experimental
- Talimogene laherparepvec: Cycle 1 - 10^6 PFU/mL. Cycle 2, 3, 4 & 5 - 10^8 PFU/mL.
- Atezolizumab 840 mg
干预措施: Talimogene laherparepvec (Biological)
Talimogene laherparepvec + Atezolizumab
Experimental
- Talimogene laherparepvec: Cycle 1 - 10^6 PFU/mL. Cycle 2, 3, 4 & 5 - 10^8 PFU/mL.
- Atezolizumab 840 mg
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Rate of residual cancer burden class 0 and 1 (RCB0/1)
时间窗: 24 months since first patient in
As a dichotomous measure of tumor response, RCB 0/1 yes vs. no., after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per local assessment.
次要结局
- Tumor ORR(24 months since first patient in)
- Rate of residual cancer burden (RCB)(24 months since first patient in)
- Changes in the expression of a gene signature tracking activated CD8 T-cells.(24 months since first patient in)
- Rate of pCRB (ypT0/Tis) and pCRBL (ypT0/TisypN0)(24 months since first patient in)
- Incidence, duration and severity of AEs assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4(24 months since first patient in)
研究者
研究点 (4)
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