Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Safety as measured by adverse event reporting (CTCAE)
研究概览
简要总结
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
- •Complete or partial response following standard of care surgery and first line chemotherapy
- •May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
- •Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
- •Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
- •Ambulatory with an ECOG 0-1
- •Life expectancy > 6 months
- •Meet protocol-specified lab requirements
- •Provide informed consent and have ability to comply with protocol requirements
排除标准
- •Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
- •Prior receipt of survivin based vaccines
- •Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
- •Progressive disease (rising CA-125 acceptable)
- •More than one course of chemotherapy for recurrent disease
- •Concurrent bevacizumab as maintenance therapy
- •Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- •History of autoimmune disease
- •Recent history of thyroiditis
- •Presence of a serious acute infection or chronic infection
- •Brain metastases
- •Other serious intercurrent chronic or acute illness
- •Ongoing treatment with steroid therapy or other immunosuppressive
- •Acute or chronic skin disorders
研究组 & 干预措施
Cohort 1
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
Cohort 1
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
Cohort 2
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
Cohort 2
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
Cohort 3
3 Doses DPX-Survivac (1 prime, 2 boost q8w)
Low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
Cohort 3
3 Doses DPX-Survivac (1 prime, 2 boost q8w)
Low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
Cohort 4
5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w)
Low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
Cohort 4
5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w)
Low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
Cohort 5
5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w)
Low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
Cohort 5
5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w)
Low dose cyclophosphamide
干预措施: DPX-Survivac(Aqueous) (Biological)
Cohort 5
5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w)
Low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Safety as measured by adverse event reporting (CTCAE)
时间窗: up to 11 months
次要结局
- Cell mediated immunity as measured by the antigen specific response in peripheral blood(up to 11 months)
- Impact on residual tumour(up to 11 months)