EUCTR2021-001492-16-IT招募中1 期
Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab - NADINA - NADINA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 420
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
- 性别
- All
入选标准
- •Men and women, at least 16 years of age;
- •World Health Organization (WHO) Performance Status 0 or 1;
- •Cytologically or histologically confirmed resectable stage III melanoma of cutaneous or unknown primary origin with one or more macroscopic lymph node metastases (clinical detectable),
- •that can be biopsied and a maximum of 3 additional resectable in-transit metastases. A concurrent resectable primary melanoma is allowed. Clinical detectable lymph nodes are defined as
- •either one:
- •-a palpable node, confirmed as melanoma by pathology;
- •-a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;
- •-a PET scan positive lymph node of any size confirmed as melanoma by pathology;
- •No other malignancies, except adequately treated and with a cancer-related life-expectancy of more than 5 years;
- •No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1;
- •No prior targeted therapy targeting BRAF and/or MEK;
- •No immunosuppressive medications within 6 months prior study inclusion (steroids equivalent to prednisolone =10 mg are allowed);
- •Screening laboratory values must meet the following criteria: WBC =2.0x109 /L, neutrophils =1.5x109 /L, platelets =100x109 /L, hemoglobin =5.5 mmol/L, creatinine =1.5xupper limit of
- •normal (ULN), AST =1.5x ULN, ALT =1.5x ULN, bilirubin =1.5x ULN (except for subjects with Gilbert syndrome who must have a total bilirubin < 3.0 mg/dL);
- •LDH level < 1.5x ULN;
- •Women of childbearing potential (WOCP) must use appropriate method(s) of contraception, i.e. methods with a failure rate of < 1% per year when used consistently and correctly, to avoid
- •pregnancy for 23 weeks post last ipilimumab + nivolumab infusion;
- •Males who are sexually active with WOCP must use appropriate method(s) of contraception, i.e. methods with a failure rate of < 1% per year when used consistently and correctly, to avoid
- •pregnancy for 31 weeks post last ipilimumab + nivolumab infusion;
- •Patient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, tumor biopsies and extra
- •blood withdrawal during screening and in case of recurrence, and other requirements of the study;
- •Patient has signed the Informed Consent document.
- •Are the trial subjects under 18? yes
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Distantly metastasized melanoma;
- •Uveal/ocular or mucosal melanoma;
- •in-transit metastases only (without cytological or histological proven lymph node involvement)
- •Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications.
- •Subjects with resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as
- •vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll;
- •Prior radiotherapy targeting the affected lymph node region(s);
- •Subjects will be excluded if they test positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. Subjects
- •treated and being at least one year free from HCV are allowed to participate;
- •Subjects will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- •Subjects with history of allergy to study drug components or history of severe hypersensitivity reaction to monoclonal antibodies.
- •Subjects with underlying medical conditions or active infection that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity
- •or adverse events;
- •Women who are pregnant or breastfeeding;
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids >10 mg prednisolon daily
- •equivalent;
- •Use of other investigational drugs before study drug administration 30 days or 5 half-times before study inclusion;
- •Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with
- •the subject before registration in the trial.
研究者
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