EUCTR2016-003946-99-ES进行中（未招募）1 期
A multicenter phase 2 study of nivolumab combined with ipilimumab in patients with pediatric solid tumors presenting in adulthood
Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI)0 个研究点目标入组 98 人开始时间: 2017年3月31日最近更新:
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
- 98
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
- •1.Subjects must be = 18 years of age, and any subjects of any gender is allowed.
- •2.Subjects must have histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic childhood malignancies:
- •a.Medulloblastoma
- •b.Hepatoblastoma
- •c.Neuroblastoma
- •d.Wilms’ tumor
- •e.Retinoblastoma
- •f.Pinealoblastoma
- •g.Pancreatoblastoma
- •h.Askin’s tumor and Ewing family of tumors
- •i.Langerhans cell histiocytosis
- •j.Other pediatric malignancies: to be discussed with steering comitee.
- •3.Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score =2.
- •4.Subjects must have at least one site of measurable/evaluable disease on CT/MRI scans. Baseline imaging must be performed within 30 days of Day 1 of study.
- •5.Patients may have received prior standard therapy as defined by the attending physician for every tumor subtype. Cases not candidate for standard therapies will be allowed in the trial, according to the attending physician criteria. Additionally those tumors where standard therapy does not exist will be also eligible.
- •6.Subjects must have adequate electrolyte values, bone marrow, renal and liver functions at screening as defined below:
- •a.WBC = 2 x 109/L
- •b.Absolute neutrophil count (ANC) = 1.5 x 109/L
- •c.Platelets = 100 x 109/L
- •d.Hemoglobin = 9.0 g/dL
- •e.Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) 40 mL/min (if using Crockcroft-Gault formula below):
- •i.Female CrCl = (140 – age in years) x weight in kg x 0.85
- •72 x serum creatinine in mg/dL
- •ii.Male CrCl = (140 – age in years) x weight in kg x 1.00
- •72 x serum creatinine in mg/dL
- •f.Total Bilirubin = 2 x ULN (unless elevated secondary to benign?conditions such as Gilbert’s disease, who can have total bilirrubine < 3.0 mg/dL)
- •g.AST and ALT = 3 x ULN (except patient with liver metastasis who can have values = 5 x ULN)
- •7.Subjects must be capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening study-specific procedures.
- •8.Women of childbearing potential (WOCBP) 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 nivolumab.
- •9.Women of childbearing potential (WOCBP) must agree to use appropriate and effective method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy from Day 1 of study and for 5 months (time required for nivolumab to undergo 6,1 half-lives) after the last dose of investigational drug administration. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. These durations have been calculated using the upper limit of the half-life for nivolumab and are based on the protocol requirement that WOCBP use contraception for 6,1 half-lives and men who are sexually active with WOCBP use contraception for 8,5 half-lives. Effective methods of birth control include:
- •a.total abstinence from sexual intercourse (if it is the subject’s preferred and usual lifestyle; for beginning a minimum one complete menstrual cycle prior to study drug administration and to extend 6 months after treatment);
- •b.vasectomized subject or partner(s); vasectomy (males);
排除标准
- •1.Subjects should be excluded if they have had prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- •2.Subjects who are curable by conventional multidisciplinary management.
- •3.Subjects with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
- •4.Subjects who have received wide field radiotherapy = 4 weeks or limited field radiation for palliation < 2 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy.
- •5.Subjects who have active infections requiring therapy.
- •6.Subjects should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- •7.Subjects should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •8.Subjects that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- •9.Subjects who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
- •a.Subjects who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment prior to starting study drug.
- •b.Patients who have received biologic therapy within a period of time that is = 5 t1/2 or = 4 weeks (whichever is shorter) prior to starting study drug.
- •c.Patients who have been treated with continuous or intermittent small molecule therapeutics within a period of time that is = 5 t1/2 or = 4 weeks (whichever is shorter) prior to starting study drug.
- •d.Patients who have received any other investigational agents within a period of time that is = 5 t1/2 or less than the cycle length used for that treatment or = 4 weeks (whichever is shorter) prior to starting study drug.
- •10.Subjects who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting study drug.
- •11.Subjects who have undergone major surgery = 2 weeks prior to starting study drug.
- •12.Subjects with active, known or suspected autoimmune disease or a documented history of autoimmune disease.
- •13.Women who are pregnant or nursing/breastfeeding.
- •14.Subjects who have known hypersensitivity to nivolumab or ipilimumab or another mAb.
- •15.Subjects with a history of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease.
- •16.Subjects with untreated central nervous system disease.
- •17.Subjects who have any inability to comply with protocol required procedures.
- •18.Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •19.Subjects who have received a live vaccine within 30 days prio
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