A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- The rate of tumor positive sentinal lymph node (SLN)
研究概览
简要总结
Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is
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)
盲法说明
Persons that are masked/ blinded for which medication the patient receives: participant, treating physician/ team (including the person giving the intradermal injection) and peron who collects the data.
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
- •18 years or older
- •Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- •Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)
- •World Health Organization (WHO) Performance Status ≤1
- •Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration
- •Written informed consent
排除标准
- •Known hypersensitivity to any oligodeoxynucleotide
- •Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
- •Pathologically confirmed loco-regional or distant metastasis
- •Non-skin melanoma
- •Patients with another primary malignancy (some exceptions)
- •Active systemic infections requiring antibiotics
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Tilsotolimod (IMO-2125)
Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
干预措施: Tilsotolimod (Drug)
Placebo
Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
干预措施: Saline (0.9% sodium chloride) (Drug)
结局指标
主要结局
The rate of tumor positive sentinal lymph node (SLN)
时间窗: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
The rate of tumor positive sentinal lymph node (SLN)
次要结局
- Immune response in the SLN and peripheral blood(Seven days after the intradermal injection of Tilsotolimod (IMO-2125))
- Recurrence free survival (RFS)(At 5 years and 10 years after sentinel node biopsy (SNB))
- Overall survival(At 5 years and 10 years after sentinel node biopsy (SNB))
研究者
A.J.M. van den Eertwegh
Principal Investigator
Amsterdam UMC, location VUmc