NCT05496192撤回2 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
Bristol-Myers Squibb3 个研究点 分布在 2 个国家开始时间: 2023年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)
研究概览
简要总结
The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
- •All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.
排除标准
- •History of ocular or uveal or mucosal melanoma.
- •Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
- •Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab IV followed by Nivolumab SC
Experimental
干预措施: Nivolumab/rHuPH20 (Drug)
Nivolumab IV followed by Nivolumab SC
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)
时间窗: Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)
次要结局
- Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)(Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days))
- Number of Participants with Adverse Events (AEs)(Up to 100 days following last dose of nivolumab (Up to Day 465))
研究者
研究点 (3)
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