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临床试验/NCT03390738
NCT03390738撤回2 期

Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy

The University of Hong Kong0 个研究点开始时间: 2018年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Dora Kwong

Clinical Professor

The University of Hong Kong

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