NCT02107378终止2 期
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma
SOTIO a.s.0 个研究点目标入组 22 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 主要终点
- Overall survival (all cause mortality)
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).
详细描述
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18 years or older
- •Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (serous, endometrioid or mucinous), who have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons
- •Patients are platinum-refractory (no response)
- •Complete remission was not reached (partial responders)
- •Relapse within ≤6 months of remission (Platinum-resistant)
- •Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
排除标准
- •FIGO I,II epithelial ovarian cancer
- •FIGO III, IV clear cells epithelial ovarian cancer
- •Non-epithelial ovarian cancer
- •Borderline tumors (tumors of low malignant potential)
- •Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab)
- •Previous radiotherapy to the abdomen and pelvis
- •Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
- •Clinically significant cardiovascular disease
- •Active autoimmune disease requiring treatment
- •History of severe forms of primary immune deficiencies
- •Systemic immunosuppressive therapy for any reason
研究组 & 干预措施
DCVAC/OvCa in parallel with chemo (SoC)
Experimental
Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
干预措施: DCVAC/OvCa (Biological)
Standard of Care (Chemotherapy)
Active Comparator
Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
干预措施: Standard of Care (Paclitaxel or topotecan or doxorubicin) (Drug)
结局指标
主要结局
Overall survival (all cause mortality)
时间窗: 72 weeks
次要结局
- Progression Free Survival(72 weeks)
- Objective Response Rate(0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks)
- Immunological Response(0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks)
- Biological Progression Free Interval(0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks)
- Frequency of Adverse Events(0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks)
- Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian(0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks)
研究者
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