EUCTR2016-001984-35-DK进行中（未招募）1 期
‘Multicenter Phase 2 Study to Identify of the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo) and Personalized Response-driven Adjuvant Combination (PRADO extension cohort) - OpACIN-neo and PRADO
Antoni van Leeuwenhoek ziekenhuis0 个研究点目标入组 200 人开始时间: 2019年5月7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
- 200
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
- •Adults at least 18 years of age
- •World Health Organization (WHO) Performance Status 0 or 1
- •Cytologically and histologically confirmed resectable stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST 1.1), that can be biopsied, and no history of in-transit metastases within the last 6 months
- •No other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years
- •Patient willing to undergo triple tumor biopsies and extra blood withdrawal during screening and in case of relapse
- •No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
- •No immunosuppressive medications within 6 months prior study inclusion
- •Screening laboratory values must meet the following criteria: WBC = 2.0x109/L, Neutrophils =1.5x109/L, Platelets =100 x109/L, Hemoglobin =5.5 mmol/L, Creatinine =1.5x ULN, AST = 1.5 x ULN, ALT = 1.5 x ULN, Bilirubin =1.5 X ULN
- •Normal LDH
- •Women of childbearing potential (WOCBP) must use appropriate method(s) of contra-ception, i.e. methods with a failure rate of <1% per year when used consistently and correctly. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
- •Women of childbearing potential must have a negative serum or urine pregnancy test
- •(minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of
- •ipilimumab + nivolumab
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure
- •rate of less than 1% per year. Men receiving nivolumab and who are sexually active with
- •WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last
- •dose of investigational product
- •Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically
- •sterile as well as azoospermic men do not require contraception
- •Patient is capable of understanding and complying with the protocol requirements and has
- •signed the Informed Consent document.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Distantly metastasized melanoma
- •Brain metastases
- •History of in-transit metastases within the last 6 months
- •No measurable lesion according to RECIST 1.1
- •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 CTLA-4 or PD-1/PD-L1 targeting immunotherapy
- •Radiotherapy prior or post-surgery (except for non-responders in PRADO extension cohort;
- •in this group is adjuvant radiotherapy allowed)
- •Patients will be excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection
- •Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Allergies and Adverse Drug Reaction
- •- History of allergy to study drug components
- •- History of severe hypersensitivity reaction to any monoclonal antibody
- •Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
- •Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion
研究者
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