JPRN-jRCT2080223779已完成3 期
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Males and Females, ages 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- •Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
- •Treatment-naive participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
- •Measurable disease per RECIST v1.1
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Uveal or ocular melanoma
- •Participants with active, known, or suspected autoimmune disease
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
研究者
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