EUCTR2016-004614-10-DE进行中（未招募）1 期
An open label phase II study to evaluate safety and efficacy of combined treatment with ipilimumab and nivolumab in patients with four and more symptomatic brain metastases of melanoma - BRAIN-IP
niversity Hospital Tübingen0 个研究点目标入组 68 人开始时间: 2017年1月16日最近更新:
适应症
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
- 68
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
入选标准
- •1.Signed Informed Consent (ICF) prior to any screening procedures being performed
- •2.Ability to comply with protocol requirements
- •3.Metastatic histologically confirmed melanoma (per AJCC staging system) that is unresectable
- •4.Presence of four or more active brain metastasis confirmed/evaluated by MRI
- •Patients with symptomatic brain metastases will be defined as subjects with brain metastases and any of the following: focal neurological deficits, seizures, headache or any other neurological and/or psychiatric alteration with temporal relation to the diagnosis of CNS disease
- •5.Measurable disease by MRI per iRANO and RECIST 1.1 criteria
- •6.The time between the baseline MRI and the date of registration should not exceed 28 days. Steroid treatment is permissible before brain MRI evaluation but the dose should have been stable for at least 7 days and should be carefully documented
- •7.Patient must agree to the cerebro-spinal fluid (CSF) collections which are planned according to the study protocol.
- •8.Patients naïve for systemic treatment are eligible
- •9.Patients pre-treated with systemic immunotherapy, targeted therapy or chemotherapy are eligible, with the exception of previous treatment with the combination of CTLA-4 and PD-1 antibodies (see exclusion criterion 2)
- •10.Patients must have recovered completely from any treatment-related acute toxicity associated with prior therapy
- •11.At least two weeks must have passed since the last systemic anti-cancer treatment
- •12.Patients with prior local therapy of brain metastases are eligible
- •13.Patients may have received irradiation therapies:
- •b.B) Whole brain irradiation only
- •c.C) Stereotactic irradiation of single or few metastases. Such lesions cannot be selected as target lesions and must therefore be excluded for the evaluation of the IC-DCR
- •d.D) Combined B+C)
- •14.Screening laboratory values must meet the following criteria (using CTCAE v4.0)
- •and should be obtained within 14 days prior to registration:
- •WBC = 2,000/µL
- •Neutrophils = 1,500/µL
- •Platelets = 100 x103/µL
- •Hemoglobin > 9.0 g/dL
- •Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 40 mL/min (if using the Cockcroft-Gault formula below):
- •oFemale CrCl = (140 - age in years) x weight in kg x 0.85 / (72 x serum creatinine in mg/dL)
- •oMale CrCl = (140 - age in years) x weight in kg x 1.00 / (72 x serum creatinine in mg/dL)
- •AST/ALT= 3 x ULN
- •Total bilirubin = 1.5 x ULN (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- •INR = 1.5
- •15.ECOG Performance Status 0, 1 or 2
- •16.Expected life expectancy of =three months
- •17.Males and females = 18 years old
- •18.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- •19.Women must not be breastfeeding
- •20.Women of childbearing potentia
排除标准
- •1.Diagnosed ocular melanoma
- •2.Previous systemic therapy with the combination of CTLA-4 and PD-1 antibodies
- •3.Use of any investigational or non-registered product within the 30 days before registration in the study
- •4.Prior active malignancy within the previous 3 years except locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast
- •5.History of organ transplantation
- •6.Active infection requiring systemic therapy
- •7.Active, known or suspected autoimmune disease.
- •Exceptions: Patients with controlled Type I diabetes mellitus (patients who keep their preprandial blood glucose within the target range of 4 to 7 mmol/L), hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, can be enrolled.
- •8.Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- •9.Any serious or uncontrolled medical disorders thatmay increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results in the opinion of the investigator.
- •10.Known substance abuse or psychiatric disorders that would preclude cooperation with tany requirements of the trial.
- •11.Legal incapacity or limited legal capacity
- •12.Administration of live, attenuated vaccine within 4 weeks prior to the start of study drug
- •13.Positive test for hepatitis B virus surface antigen (HBs Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- •14.Known history of a positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •15.Patients with known allergy or hypersensitivity to any of the study drugs or excipients
- •Patients with results of imaging or radiological examinations indicating increased cerebral pressure which would prevent lumbar puncture
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