EUCTR2017-002499-14-IT进行中(未招募)1 期
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined withNivolumab versus Nivolumab in Participants with Metastatic orUnresectable Melanoma that is Previously Untreated - ooo
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Per Revised Protocol 01, enrollment in the current study has been stopped as of 19-Apr-2018
- •- 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-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
- •- Measurable disease
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 634
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 271
排除标准
- •Per Revised Protocol 01, enrollment in the current study has been stopped as of 19-Apr-2018
- •- 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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