JPRN-jRCT2031230360招募中3 期
A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO(R) (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
Medical Information0 个研究点目标入组 15 人开始时间: 2023年9月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 99age old（—）
- 性别
- All
入选标准
- •At least 18 years of age
- •- Completely removed melanoma by surgery performed within 12 weeks of randomization
- •- Advanced Melanoma
- •- Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
- •- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •- Other protocol-defined inclusion criteria apply
排除标准
- •- Previous anti-cancer treatment
- •- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
- •- Ocular or uveal melanoma or history of carcinomatosis meningitis
- •- History of auto-immune disease
- •- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
- •- Other protocol-defined inclusion/exclusion criteria apply
研究者
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