NL-OMON54971招募中不适用
Multicenter Phase 1b trial testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in IFN-gamma signature-low and IFN-gamma signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma -DONIMI. - DONIMI
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- •- Adults at least 18 years of age.
- •- World Health Organization (WHO) Performance Status 0 or 1.
- •- Cytologically or histologically confirmed resectable stage III cutaneous
- •melanoma (unknown primary also allowed) 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.
- •- IFN-gamma signature low or high according to the NanoString test (IFN-gamma
- •signature intermediate not allowed).
- •- No other malignancies, except adequately treated and a cancer-related
- •life-expectancy of more than 5 years.
- •- Patient willing to undergo quadruple tumor biopsies and extra blood
- •withdrawal during screening, week 3 and in case of relapse.
- •- No immunosuppressive medications within 6 months prior trial registration.
- •- 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
- •- Normal LDH.
- •- 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.
- •- Patient is capable of understanding and complying with the protocol
- •requirements and has signed the Informed Consent document.
排除标准
- •- Distantly metastasized melanoma.
- •- Uveal or mucosal melanoma.
- •- History of in-transit metastases within the last 6 months.
- •- No measurable lymph node 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.
- •- Patients with any active gastrointestinal disorder that could interfere with
- •the absorption of domatinostat (as per judgement of the investigator), such as
- •ulcerative colitis, Crohn*s disease, diabetic gastroparesis, or other syndromes
- •characterized by malabsorption.
- •- Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy.
- •- Prior radiotherapy.
- •- 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
- •- 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 or adverse events.
- •- Patients with a marked baseline prolongation of QT/QTc interval, e.g.,
- •repeated demonstration of a QTc interval >450 msec (Grade 1 NCI-CTCAE);
- •Long-QT-Syndrome) and patients receiving agents known to prolong the QT
- •interval and known risk of Torsades de Pointes.
- •- Patients with significant current cardiovascular disease including:
- •- Unstable angina pectoris within 6 months prior to screening
- •- Uncontrolled hypertension
- •- Congestive heart failure (New York Heart Association (NYHA) Class III or
- •IV) related to primary cardiac disease
- •- Conditions requiring anti-arrhythmic therapy (patients with status post
- •pace maker implantation can be included)
- •- Symptomatic ischemic or severe valvular heart disease, or a myocardial
- •infarction within 6 months prior to the trial entry
- •- Women who are pregnant or lactating
- •- Use of other investigational drugs before study drug administration 30 -days
- •and 5 half-times before trial registration.
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