NCT02632409已完成3 期
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 318
- 主要终点
- Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
- •Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
- •Must have disease free status as determined by imaging within 4 weeks of dosing
- •Tumor tissue must be provided for biomarker analysis
- •Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
排除标准
- •Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
- •Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
- •Subjects 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
- •Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
- •Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo dose as specified
干预措施: Placebo (Other)
Nivolumab
Experimental
Nivolumab dose as specified
干预措施: Nivolumab (Biological)
结局指标
主要结局
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
时间窗: approximately up to 48 months
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Disease Free Survival (DFS)
时间窗: approximately up to 48 months
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
次要结局
- Overall Survival in Participants With PD-L1 Expression ≥ 1%(on going)
- Non-Urothelial Tract Recurrence Free Survival(up to 53 months)
- Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%(on going)
- Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population(up to 53 months)
- Overall Survival(on going)
- Disease Specific Survival(on going)
研究者
研究点 (318)
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