A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.
详细描述
All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
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
- •Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
- •Without disease progression during preceding platinum-based chemotherapy
- •Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression.
- •First relapse identified by the criteria above up to 28 days prior to study randomization
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Known BRCA (breast cancer susceptibility gene) mutation status before randomization
- •Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi
排除标准
- •Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed
- •Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy
- •Intention to treat with intra-peritoneal chemotherapy
结局指标
主要结局
Overall Survival(OS)
时间窗: Assessed from enrolment up to study completion, approximately 6.6 years
Defined as the time from randomization until the date of death due to any cause.
次要结局
- Objective Response Rate(Assessed from start of treatment to up to 4 years)
- Duration of Response(Assessed from start of study treatment up to 4 years)
- Biological Progression-Free Survival(Assessed from randomization up to study completion up to 6.6 years.)
- Progression-Free Survival (PFS)(Assessed from enrollment to up to 4 years)
- Time to Relapse(Assessed from start of treatment up to 4 years)
- Safety Assessments: NCI CTCAE version 5.0(Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.)