Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma - NADINA - NADINA

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

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

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:
•o a palpable node, confirmed as melanoma by pathology,or;
•o a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15
•mm in short axis), confirmed as melanoma by pathology, or;
•o 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, PD-L1 or LAG-3;
•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 during and until 23 weeks post
•last ipilimumab + nivolumab infusion;
•Males who are sexually active with WOCP are not required to use contraception
•during treatment with nivolumab +/- ipilimumab, but 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 during and until 17
•weeks post last dabrafenib + trametinib administration;
•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 relapse, and other requirements of the study;
•Patient has signed the Informed Consent document.

排除标准

•Distantly metastasized melanoma;
•Uveal/ocular or mucosal 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. Subjects with vitiligo, 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
•Subjects with history of allergy to study drug compononents 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 prednisolone 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

研究者

发起方

Antoni van Leeuwenhoek Ziekenhuis

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