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临床试验/NL-OMON52016
NL-OMON52016招募中2 期

Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ) - NESCIO

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 46 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
46
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

年龄范围
18 至 64（—）

入选标准

  • •Adults at least 18 years of age
  • •World Health Organization (WHO) Performance Status 0 or 1
  • •Histologically confirmed resectable clear cell RCC (measurable according to
  • •RECIST 1.1), that can be biopsied, and no history of distant metastases
  • •Intermediate to high risk will be based on clinical TNM and biopsy nuclear
  • •grade. These are:
  • •1. cT1b-cT2a grade 4 cN0 cM0
  • •2. cT2b grade 3-4 cN0 cM0
  • •3. cT3 any grade cN0 cM0
  • •4. cT4 any grade cN0 cM0
  • •5. cT any cN1 (fully resectable) cM0
  • •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, or LAG-3
  • •No immunosuppressive medications within 2 weeks prior start immunotherapy
  • •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 CK and Troponin T, normal LDH
  • •Women of childbearing potential must use appropriate method(s) of
  • •contraception. They 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 study treatment
  • •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.

排除标准

  • •Distantly metastasized RCC • Brain metastases (based on symptoms) • Non-clear
  • •cell RCC • 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 or LAG-3 targeting immunotherapy •
  • •Radiotherapy prior or post-surgery • 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; if
  • •treated and being at least one year free from HCV patients are allowed to
  • •participate • 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 Reactions (like
  • •mastocytosis) • 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(s) hazardous or obscure the
  • •interpretation of toxicity or adverse events; • Pregnant or nursing •
  • •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
  • •Relatlimab-specific exclusion criteria • Participants with history of
  • •myocarditis, regardless of etiology. • Troponin T (TnT) > 2 × institutional
  • •ULN. Participants with TnT levels between > 1 to 2 × ULN will be permitted if a
  • •repeat levels within 24 hours are <= 1 ULN. If TnT levels are between >1 to 2 ×
  • •ULN within 24 hours, the participant may undergo a cardiac consultation and be
  • •considered for treatment, following cardiologist recommendation. When repeat
  • •levels within 24 hours are not available, a repeat test should be conducted as
  • •soon as possible. If TnT repeat levels beyond 24 hours are < 2 × ULN, the
  • •participant may undergo a cardiac consultation and be considered for treatment,
  • •following cardiologist recommendation. Notification of the decision to enroll
  • •the participant following cardiologist recommendation has to be made to the BMS
  • •Medical Monitor or designee. • Left ventricular ejection fraction (LVEF)
  • •assessment with documented LVEF < 50% by either transthoracic echocardiogram
  • •(TTE) or multigated acquisition (MUGA) scan (TTE preferred test) within 6
  • •months prior to start of study treatment.

研究者

发起方
Antoni van Leeuwenhoek Ziekenhuis

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