JPRN-jRCT2051200146进行中（未招募）未知
An Open-Label,Expanded Acces Program with Nivolumab(ONO-4538)for cancer of unknown primary(CUP) - NivoCUP-2
akagawa Kazuhiko0 个研究点目标入组 60 人开始时间: 2021年3月4日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Subjects with histologically confirmed cancer of unknown primary site based on adequate investigation of primary sites (excludes subjects who were pathologically diagnosed with malignant melanoma, malignant lymphoma or sarcoma)
- •2.Treatment naive or previously treated
- •3. Men and women above 20-years of age
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •5. Expected more than 90 days survival
- •6. Have a Evaluable disease(With or without measurable lesions in RECIST 1.1)
- •7. SpO2 at room air is higher than 94% by pulse oximeter within 7 days before registration
- •8.Patients whose latest laboratory test values performed within 7 days before enrollment meet the following criteria
- •9.Women of childbearing potential must agree to follow instructions for methods of contraception from the time of enrollment for the duration of treatment with nivolumab plus 5 months post-treatment completion. Women must not be breastfeeding
- •10.Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines
排除标准
- •1. Indication for curative surgery or radiotherapy
- •2. Favorable subsets under treatable condition
- •3. Proven primary site before enrollment
- •4. Subjects with an active, chronic or recurrent autoimmune disease
- •5. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- •6. Prior therapy with drug targeting immune-checkpoint pathways
- •7. History of allergy or hypersensitivity to drug components
- •8. Judged that the adverse events from the previous treatment influence on the study evaluation
- •9. Subjects with untreated symptomatic CNS metastases
- •10. Subjects with interstitial lung disease
- •11. Anti-cancer therapy within 14 days before enrollment
- •12. Subjects who were treated with radiotherapy within 14 days (radiotherapy for thoraciclesion within 28 days) before enrollment
- •13. Surgery requiring local or surface anesthesia or general anesthesia within 14 days before enrollment
- •14. Subjects with diverticulitis or symptomatic gastrointestinal ulcer disease
- •15. Subjects with uncontrollable diabetes
- •16. Subjects with uncontrollable pleural effusion, ascites or pericardial effusion requiring treatment
- •17. Subjects with stroke, cerebrovascular accident, thrombosis, or thromboembolism within 90 days before enrollment
- •18. Subjects with known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- •19. Subjects with systemic infection requiring treatment
- •20. Subjects with uncontrolled or severe cardiovascular disease, congestive heart failure,
- •arrhythmias, pericardial disease or cardiac amyloidosis within 90 days before enrollment
- •21. Subjects with uncontrolled intercurrent illness, including mental disorder
- •22. Subjects with other active malignancy
- •23. History of organ transplantation or hematopoietic stem cell transplantation
- •24. Women who are pregnant or breast feeding
- •25. Subjects be in a state lacking consent ability
- •26. Subjects with unsuitable condition judged by principal investigato
研究者
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