A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Tumour response rate, defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
研究概览
简要总结
The purpose of this study is to elucidate whether SentoClone® gives improved treatment responses in patients with advanced malignant melanoma in comparison to established reference treatment(s).
详细描述
Malignant melanoma is one of the most common cancer forms worldwide and WHO estimates 132,000 new cases each year. The incidence rate vary up to 150-fold between different regions and ethnicities, the highest rates are found in emigrated Caucasian populations (e.g. Australia and New Zealand).
There are few therapy alternatives for advanced malignant melanomas. At present, dacarbazine (Dacarbazine Medac®) is the most commonly used therapy. Immunotherapy with IL-2 and IFN is an alternative, but it is associated with multiple side effects. Hence, there remains a considerable need for alternative treatments.
By using SentoClone®, autologous tumour-reactive lymphocytes are expanded and infused to the patient, where they have the opportunity to seek out and attack the primary tumour and metastases. The first step is to identify the tumour draining lymph node(s), which is done in parallel to surgical resection of the primary tumour or metastasis. The sentinel and/or metinel node(s), the initial meeting place between tumour antigen and the immune system, are further dissected and collected during the surgery.
In this study SentoClone® will be compared with Dacarbazine Medac® and Temodal® which are currently regarded as standard first-line therapies in advanced malignant melanoma.
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
- None
入排标准
- 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
SentoClone®
SentoClone®: Specific tumour-reactive lymphocytes located in lymph nodes directly draining primary tumours or metastases are identified and expanded. These lymphocytes are infused to the patient to treat metastatic disease.
干预措施: SentoClone® (Biological)
Temodal® or Dacarbazine Medac®
To be decided by each centre as one of the following:
- Temodal® (temozolomide)
- Dacarbazine Medac® (dacarbazine) The reference treatment regimen should follow the general guiding principles for each of the two reference treatments.
干预措施: Temodal® or Dacarbazine Medac® (Drug)
结局指标
主要结局
Tumour response rate, defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
时间窗: At baseline and 18, 26 and 34 weeks after treatment
次要结局
- Progression-free survival(From baseline to week 34 after initiated treatment)
- Overall survival(From baseline to week 34 after initiated treatment)
- Time to tumour progression(From baseline to week 34 after initiated treatment)
- Disease-free survival(From baseline to week 34 after initiated treatment)
- Time to treatment failure(From baseline to week 34 after initiated treatment)
- Duration of response(From baseline to week 34 after initiated treatment)
- Correlation between tumour response and tumour marker S100(From baseline to week 34 after initiated treatment)
- Proportion of patients showing toxic symptoms according to CTCAE criteria(From baseline to week 34 after initiated treatment)
- Quality of life (EQ-5D and QLQ-C30)(From baseline to week 34 after initiated treatment)
- Adverse Events (AEs) classified according to seriousness, causality, and intensity, clinically significant deviations in vital signs, clinical chemistry, and haematology(From baseline to week 34 after initiated treatment)