NCT04928365Unknown2 期
Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
Blokhin's Russian Cancer Research Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- •Age of patients - 18 years and older
- •No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- •Adequate contraception for women of childbearing age
- •Written consent of the patient to participate in the study
排除标准
- •Non-compliance with the previously listed criteria
- •Pregnancy and breastfeeding
- •Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
- •History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
研究组 & 干预措施
Advanced melanoma patients
Other
干预措施: Anti-PD-1 monoclonal antibody (Drug)
Stage III and IV melanoma patients after radical surgery
Other
干预措施: Anti-PD-1 monoclonal antibody (Drug)
结局指标
主要结局
Overall survival
时间窗: up to 12 months
Progression free survival
时间窗: up to 12 months
次要结局
- Cytokine profile(up to 12 months)
研究者
Irina Mikhaylova
Principal investigator
Blokhin's Russian Cancer Research Center
研究点 (1)
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