An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Progression Free Survival by modifications to the RECIST 1.1
研究概览
简要总结
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)
详细描述
All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.
After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.
Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
- •Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
- •Laboratory parameters per protocol
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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
- •fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
- •Pregnant of lactating women
- •Pre-defined co-morbidities
- •Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
研究组 & 干预措施
Standard of care chemotherapy + DCVAC/Ov
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
干预措施: DCVAC/OvCa (Biological)
Standard of care chemotherapy + DCVAC/Ov
Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
干预措施: Standard of Care Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival by modifications to the RECIST 1.1
时间窗: Assessed from enrollment up to 104 weeks
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
次要结局
- Overall survival(Assessed from enrolment through study completion approximately 5 years)
- Immunologic Response(Blood samples collected 5 times throughout the study from enrolment up to 104 weeks)
- Biological progression-free interval(CA-125 assessed every 6 weeks up to 104 weeks)
- Time to either tumor or biologic Response(From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.)
- Objective Response rate(Response is assessed every 8 weeks up to 104 weeks)
- CA-125 response(CA-125 assessed every 6 weeks up to 104 weeks)
- Incidence of Treatment-emergent adverse events [safety and tolerability](Screening through 30 days after completion of treatment)