THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 25
- 主要终点
- Overall survival
研究概览
简要总结
This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma.
The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.
详细描述
Treatment:
Treatment with the anti-CTLA-4 mAb Ipilimumab monotherapy of each patient in the scope of this trial is defined as induction plus re-induction of eligible patients until 12 months after first receipt of study medication
Induction phase:
Ipilimumab will be applied to melanoma patients according to the protocol of the completed Medarex study MDX-010-20: Ipilimumab by IV infusion, 3 mg/kg, day 1 (Week 1), 22 (Week 4), 43 (Week 7), 64 (Week 10)
Re-induction:
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
- 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
a human immunoglobulin
Four infusions (i.v.) of 3mg/kg Ipilimumab in week 1, week 4, week 7 and week 10
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Overall survival
时间窗: alive 12 months after date from the first study drug adminstration
Overall survival rate at 12 months defined as the rate of patients alive 12 months after the date from the first study treatment for complete study
次要结局
- Efficacy according RECIST criteria(12 months after date from the first study drug administration)
- Efficacy according to immune-related response criteria (ir-RC) at any time during treatment(12 months after date from the first study drug administration)
- safety and efficacy parameters(12 months after date from the first study drug adminstration)
- To evaluate possible surrogate markers in peripheral blood and tumour biopsy (translational research program)(12 weeks after date from the first study drug administration)
- Progression free survival rate at 6 months(6 months after date from the first study drug administration)
- Overall survival at 1 year in the subgroups (cutaneous, uveal, mucosal)(12 months after date from the first study drug administration)
- To explore clinical efficacy of ipilimumab in relation to b-raf mutation status, brain metastases, LDH, HLA-A2 status(12 months after date from the first study drug administration)
- To examine the value of peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker in various patient cohorts with unresectable stage III-IV melanoma treated with ipilimumab monotherapy(12 weeks after date from the first study drug administration)
研究者
Prof. Dr. med. Dirk Schadendorf
Professor
University Hospital, Essen