JPRN-jRCT2051220186招募中Unknown
Expanded Access Program with Nivolumab (ONO-4538) for malignant non-pleural mesothelioma (VIOLA)VIOLA: niVolumab in malIgnant non-pleural mesOtheLiomA - VIOLA-EX Study
Kijima Takashi0 个研究点目标入组 15 人开始时间: 2023年3月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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.AgeOver 20 years on the date of informed consent
- •2.Pathologically confirmed non-pleural malignant mesothelioma
- •3.a.Patients with peritoneal mesothelioma having at least one measurable lesion designated according to RECIST guidelines, Version 1.1
- •b.Patients with mesothelioma originated from pericardium or tunica vaginalis without having no measurable lesions.
- •4.Advanced or metastatic MNPM (malignant non-pleural mesothelioma) that is with or without prior treatment
- •5.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6.Patients expected to survive over 90 days
- •7.Patients with percutaneous oxygen saturation over 94%, as measured by pulse oximeter at rest, without supplemental O2 within 7 days before enrollment. However, if the baseline measurement is not included within 7 days before the initial dose of the investigational product, it should be reconfirmed that the baseline measurement is met.
- •8.Patients whose latest laboratory values obtained within 7 days of enrollment meet the following criteria. However, if the laboratory test at the time of registration is not included within 7 days before the first administration of the investigational product, it should be reconfirmed that the laboratory test before the first administration of the investigational product meets the following criteria. In all cases, laboratory test values are those for which granulocyte colony-stimulating factor (G-CSF formulation) or blood transfusion was not received within 14 days before the test date. White blood cell count > 2,000/m3 and neutrophil count > 15000/m3 Platelet count >= 100,000/m3 Hb >= 8.0 g/dL AST (GOT) and ALT (GPT) are not more than 3.0 times the upper limit of the facility reference value. Total bilirubin not more than 2.0 times the upper limit of institutional standard value Serum creatinine not more than 1.5 times the upper limit of the reference value at the institution Or creatinine clearance (Cockcroft estimates) > 45 m L/min.
- •9.Patients who have been fully informed of the details of the study by the investigator or sub investigator using a written informed consent form and who voluntarily agree to participate in the study
排除标准
- •1.Complication or history of severe hypersensitivity reactions to any drugs
- •2.History of concomitant, chronic, or recurrent autoimmune diseases
- •3.Multiple cancers
- •4.Brain or meningeal metastases
- •5.Complication or history of interstitial lung disease or pulmonary fibrosis
- •6.Coexisting diverticulitis or symptomatic gastrointestinal ulcer disease
- •7.Accumulation of pericardial effusion or ascites requiring drainage every 2 weeks or more
- •8.Pain associated with uncontrollable tumors
- •9.Transient ischemic attack, cerebrovascular attack, thrombosis, or thromboembolism within 180 days before enrollment.
- •10.Uncontrolled or significant cardiovascular diseases
- •11.Receiving anticoagulant therapy, but including low-dose aspirin
- •12.Uncontrolled diabetes
- •13.Systemic infections requiring treatment
- •14.Obviously positive for human immunodeficiency virus (HIV)
- •15.HTLV-1 antibody-positive, HBs antigen-positive, or HCV antibody-positive. Either HBs antigen positive or HBc antibody-positive and HBV-DNA detection if HBs antigen is negative
- •16.Surgery with general, local, or surface anesthesia within 14 days before enrollment
- •17.Pleural, peritoneal, or pericardial adhesions within 28 days before enrollment
- •18.History of treatment for T-cell regulation within 28 days before enrollment
- •19.Palliative radiation therapy within 14 days before enrollment
- •20.Radiopharmaceuticals therapy within 56 days before enrollment
- •21.Administration of unapproved drugs within 28 days or an unapproved antibody within 90 days
- •22.Received systemic corticosteroids or immunosuppressants above 10 mg/day of prednisolone equivalent within 28 days before enrollment
- •23.Received live or attenuated vaccines within 28 days before registration
- •24.Pregnant women
- •25.Patients judged to lack the ability to consent due to complications such as dementia
- •26.Other patients judged by the investigator unsuitable for this study
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