EUCTR2022-000294-67-DE进行中（未招募）1 期
A Phase II Study of Adjuvant Nivolumab Switch from Intravenous (IV) to Subcutaneous (SC) Use in Participants with Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
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
- •- Eligible for adjuvant therapy for melanoma or muscle-invasive urothelial carcinoma originating from the bladder
- •Melanoma: resected Stage IIIA/B/C/D or Stage IV (AJCC 8th edition)
- •Bladder: pT3-pT4a or pN+ ineligible or refusal of adjuvant cisplatin chemotherapy OR ypT2-pT4a or ypN+ who received neo-adjuvant cisplatin chemotherapy
- •- ECOG performance status 0-1; =18
- •Are the trial subjects under 18? no
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Ocular or mucosal melanoma
- •Upper tract urothelial carcinoma (ureter, renal pelvis), NMIBC
- •Untreated/unresected CNS or leptomeningeal metastases
- •Prior treatment with immuno-oncology agents
研究者
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