NCT02409368已完成2 期
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Bristol-Myers Squibb90 个研究点 分布在 11 个国家目标入组 812 人开始时间: 2015年4月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 812
- 试验地点
- 90
- 主要终点
- Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
研究概览
简要总结
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •ECOG Status: PS 0-1 & PS 2
- •Subjects with histologically or cytologically-documented SqNSCLC
- •Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
- •Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
- •Subjects with treated or asymptomatic CNS metastases
- •Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
- •Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
- •Males and Females, ages 18 or older
排除标准
- •Subjects with untreated, symptomatic CNS metastases
- •Subjects with carcinomatous meningitis
- •Subjects with active, known or suspected autoimmune disease.
- •Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
研究组 & 干预措施
Cohort A: Treatment - Nivolumab
Experimental
Nivolumab IV infusion
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
时间窗: From first dose to time of analysis of primary endpoint (approximately up to 34 months)
The total number of participants with high grade treatment related select adverse events.
次要结局
- Objective Response Rate (ORR)(From first dose up to last dose (up to approximately 76 months))
- Number of Participants With High Grade Select Adverse Events(From first dose up to 100 days post last dose (up to 76 months))
- Median Time to Onset of Any Grade Select Adverse Events(From first dose up to 100 days post last dose (up to approximately 65 months))
- Median Time to Resolution of Any Grade Select Adverse Events(From first dose to up to 100 days post last dose (up to approximately 45 months))
- Overall Survival(From the first dosing up to the date of death (up to approximately 76 months))
研究者
研究点 (90)
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