A Randomized, Double--blind, Placebo-controlled Phase III Study to Evaluate Active Immunization in Adjuvant Therapy of Patients with Stage IIIB and IIIC Melanoma with Natural Dendritic Cells Pulsed with Synthetic Peptides.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 5
- 主要终点
- Recurrence-free survival rate
研究概览
简要总结
The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with matching placebo.
详细描述
This is a phase 3, randomized, double-blind, interventional study of nDC vaccination versus placebo. Dendritic cell-based immunotherapy consists of antigen-loaded autologous DC that are administered to patients with the intention of inducing antigen-specific T and B cell responses and proved safe with minimal side effects. Natural DC (nDC) consist of plasmacytoid DC and myeloid DC. Subjects will be randomized 2:1 and stratified by stage of disease, adjuvant radiotherapy, BRAF mutation status, HLA-type and nDC production centre. The treatment will be continued for a maximum of 1.5 years or until recurrence of disease, unacceptable toxicity or withdrawal from the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
nDC vaccination arm
Patients in the nDC vaccination arm will receive a maximum of 3 cycles each consisting of 3 nDC injections intranodally (3-8x10^6 nDC).
干预措施: nDC vaccination (Biological)
placebo arm
Patients will receive a maximum of 3 cycles each consisting of 3 placebo injections intranodally.
干预措施: placebo injection (Biological)
结局指标
主要结局
Recurrence-free survival rate
时间窗: 2 years
The primary objective of this study is to determine whether adjuvant nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves 2-year RFS rate as compared to treatment with matching placebo. Defined as the percentage of patients who are alive and without recurrence of melanoma 2 years after randomization.
Treatment of melanoma patients
时间窗: The primary endpoint, 2-year RFS. At data cutoff, the median duration of follow-up was 56.3 months.
Adjuvant treatment with nDC vaccination or placebo, after standard treatment
次要结局
- Overall survival(2-years and median)
- Costs (direct and indirect) of treatment(2 years)
- Tumor specific T-cell response(week 1, week 9, week 10, week 31, week 39, week 57, week 65, week 78, month 24, month 60)
- Quality of Life Questionnaires(baseline, week 14, week 26, month 12, month 24, month 36, month 60)
- QALY(2 years)
- Adverse Events related to treatment(1,5 year)