NCT03390738撤回2 期
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
研究概览
简要总结
A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include platinum based chemotherapy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy
- •Measurable disease (RECIST 1.1)
- •ECOG 2 or less
- •Life expectancy greater than 3 months
- •Adequate organ function
- •(Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged
排除标准
- •Suitable for local therapy
- •Did not have prior platinum chemotherapy
- •Immunodeficiency; immunosuppressive treatment
- •Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1
- •Other cancer treatment within 2 weeks prior to Day 1
- •Other malignancies (some exceptions)
- •CNS metastases; carcinomatous meningitis
- •Active temporal lobe necrosis or on steroid treatment
- •Autoimmune disease
- •Active, non-infectious pneumonitis
- •Active infection requiring systemic treatment
- •Hepatitis
研究组 & 干预措施
Intravenous nivolumab 240mg
Experimental
Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
时间窗: 1 year
次要结局
- Toxicities as defined by CTCAE criteria(1 year)
研究者
Professor Dora Kwong
Clinical Professor
The University of Hong Kong
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