2024-516585-11-00招募中2 期
Efficacy of immunotherapy in melanoma patients with brain metastases treated with steroids. The MEMBRAINS trial
Region Hovedstaden3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- 6 months overall survival rate
研究概览
简要总结
The project aims to prospectively evaluate the effect of anti-PD-1 antibodies alone or in combination with anti-CTLA-4 antibodies in patients with melanoma metastasized to the brain in need of steroid treatment
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed metastatic melanoma with radiologically verified brain metastasis
- •Need for systemic steroid treatment (prednisolone > 10 mg daily; dexamethasone > 1.6 mg daily, hydrocortisone > 40 mg daily or equivalent) due to brain metastasis
- •At least one measurable lesion according to RECIST version 1.1 guidelines
- •≥ 18 years of age
- •Performance status 0-2
- •Able to undergo MRI with gadolinium contrast agent
- •Adequate hematological and organ function
- •Signed statement of consent after receiving oral and written study information
排除标准
- •Another malignancy or concurrent malignancy unless disease-free for 3 years
- •Ocular melanoma
- •Known hypersensitivity to one of the active drugs or excipients
- •Acute or chronic infections with HIV or hepatitis
- •Any medical condition that will interfere with patient compliance or safety
- •Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
- •Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
- •Simultaneous treatment with other experimental drugs or other anticancer drugs
结局指标
主要结局
6 months overall survival rate
6 months overall survival rate
6 months progression-free survival rate
6 months progression-free survival rate
次要结局
- Overall progression-free survival
- Overall survival
- Overall response rate according to modified RECIST 1.1
- Extracranial response rate in extracranial lesions according to modified RECIST 1.1
- Intracranial response rate in intracranial lesions according to modified RECIST 1.1
- Intracranial clinical benefit rate (CR+PR+SD) – proportion of patients with an overall complete, partial response or stable disease ≥ 6 months according to modified RECIST 1.1
- Blood and tissue biomarkers of response and progression
研究者
Troels Holz Borch
Scientific
Region Hovedstaden
研究点 (3)
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