NL-OMON52669招募中2 期
Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma - CHOPI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age between 18-80 years
- •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 systemic immunosuppressive medications >= 10mg/day prednisone or
- •equivalent. Topical, inhaled, nasal and ophthalmic steroids, and adrenal
- •replacement therapy are allowed.
- •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 <= 1.5 x ULN, 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
- •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
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
- •Patients with active bacterial infections with systemic manifestations
- •(malaise, fever, leucocytosis) are not eligible until completion of appropriate
- •Use of other investigational drugs before study drug administration for
- •systemic malignancy
- •Pregnancy or nursing
研究者
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