A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy.
Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.
详细描述
Study Description:
- All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure.
- ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis
- Cyclophosphamide A priming bolus dose of CPO (300 mg/m2 intravenously) will be given 1-3 days before the first (Week 5) and the fifth (Week 14) of ONCOS-102 administration.
- DCVAC/PCa therapy will start 6 weeks after leukapheresis at Week 8. DCVAC/PCa will be administered subcutaneously in cycles, always on Day 1 (+/- 3 days) of the corresponding cycle.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Radiographically documented metastatic disease with evidence of disease progression Laboratory parameters per protocol
- •Surgically or medically castrate
- •Patients who have progressed following:
- •a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or
- •b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or
- •c. failure of two lines of chemotherapy; or
- •d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy
排除标准
- •Patients with neuroendocrine or small cell cancer of the prostate
- •History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years Pre-defined co-morbidities
- •Administration of experimental therapy within the last 4 weeks before start of screening
- •Treatment with immunotherapy within the last 3 months before start of screening
- •Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
- •Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start
- •History of organ transplantation
研究组 & 干预措施
DCVac and ONCOS-102
ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses
干预措施: DCVac/PCa (Biological)
DCVac and ONCOS-102
ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 96 months
PFS measured by modifications to the RECIST 1.1. PFS is defined as the time from the first dose of SoC therapy administered to tumor progression or death from any cause.
次要结局
- Time to Progression-PSA(96 months)
- Overall Survival(96 months)
- Radiographic Progression- free survival(96 months)
- Safety(96 months)