EUCTR2018-004248-49-NL进行中（未招募）1 期
Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma (CHOPIN) - CHOPI
eiden University Medical Center0 个研究点目标入组 88 人开始时间: 2020年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 18-70 yrs
- •World Health Organization (WHO) Performance Status 0 or I
- •50% or less histologically or cytologically confirmed unresectable metastatic uveal melanoma in the parenchyma of the liver
- •Hepatic metastases, confined to or predominantly in the liver
- •No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab treatment, IL-2)
- •Local pre-treatment of uveal melanoma metastases is allowed (resection and/or thermal ablation), except for chemotherapy containing procedures (e.g. chemoembolization) and radio-embolization, and as long as patients have progressed with measurable disease according to RECIST 1.1
- •No concurrent immunosuppressive medications (including dexamethasone, prednisolone, azathioprine)
- •Screening laboratory values must meet the following criteria: WBC = 2.0x109/L, Neutrophils = 1.0x109/L, Platelets = 100 x109/L, Hemoglobin = 6.5 mmol/L, Creatinine = 2x ULN, AST = 2.5 x ULN, ALT = 2.5 x ULN, Total bilirubin = 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN
- •Women of child bearing potential (WOCBP) must agree to use a reliable form of contraceptive as described in the research protocol
- •Men must agree to the use of male contraception as described in the research protocol
- •Absence of additional severe and/or uncontrolled concurrent disease
- •No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for > 2 years.
- •No aberrant vascular anatomy of the liver that precludes PHP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Cerebral or meningeal metastasized uveal melanoma
- •Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
- •Prior immunotherapy (tumor vaccine, cytokine, or growth factor)
- •Known history of infection with Human Immunodeficiency Virus;
- •Active infection requiring therapy, positive serology for Hepatitis B surface antigen and/or Hepatitis C ribonucleic acid (RNA)
- •History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
- •History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
- •Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;
- •Latex allergy, and known hypersensitivity/allergy to ipilimumab, nivolumab, melphalan or heparin
- •Prior Whipple’s Surgery
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
- •History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation
- •Patients who are unable to be temporarily removed from chronic anti-coagulation therapy
- •Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy
- •Use of other investigational drugs before study drug administration for systemic malignancy
- •Pregnancy or nursing
研究者
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