EUCTR2013-001546-34-DE进行中（未招募）1 期
eoadjuvant treatment with the combination of Vemurafenib, Cobimetinib and Atezolizumab in limited metastasis of malignant melanoma (AJCC stage IIIC/IV) and integrated biomarker study: A single armed, two-cohort, phase II EADO trial NEO-VC - NEO-VC
niversity Hospital Tübingen0 个研究点目标入组 90 人开始时间: 2014年7月8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
- 90
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
- •Patients must meet the following criteria for study entry:
- •1.Signed Informed Consent Form
- •2.Age = 18 years
- •3.Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) mela-noma, as defined by AJCC, 7th revised edition
- •a.Naïve to prior systemic anti-cancer therapy for melanoma, with the following exceptions:
- •Adjuvant treatment with interferon (IFN), In-terleukin-2 (IL-2), or vaccine therapies, if dis-continued at least 28 days prior to initiation of study treatment
- •b.Adjuvant treatment with herbal therapies, if discontinued at least 7 days prior to initiation of study treatment
- •4.Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority.
- •If archival tumor tissue is unavailable or is de-termined to be inadequate, tumor tissue must be obtained from a biopsy performed at screening.
- •5.Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
- •6.Decision of eligibility for neoadjuvant combined vem+cobi+atezo treatment by interdisciplinary tumor board. Patient with limited numbers of metastases and few organ systems involved should be selected, making surgical resection after neo-adjuvant treatment probable.
- •7.Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST V1.1) criteria (must be outside the central nervous system (CNS))
- •8.Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment, with the exception of amylase, lipase, and lactate dehydrogenase (LDH) where up to 28 days is acceptable (using central laboratory result)
- •Absolute neutrophil cells (ANC) = 1.5 × 109/L without granulocyte colony-stimulating factor support
- •White blood cells (WBC) count = 2.5 × 109/L
- •Lymphocyte count = 0.5 × 109/L
- •Platelet count = 100 × 109/L without transfu-sion
- •Hemoglobin = 9 g/dL without transfusion
- •Serum albumin = 2.5 g/dL
- •Total bilirubin = 1.5 × the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.0 x ULN
- •Amylase and lipase = 1.5 x ULN
- •Alkaline phosphatase (ALP) = 2.5 × ULN or, for patients with documented liver or bone metastases, ALP = 5 × ULN
- •Serum creatinine = 1.5 × ULN or creatinine clearance (CrCl) = 40mL/min on the basis of measured CrCl from a 24-hour urine collection or Crockcroft-Gault glomerular filtration rate estimation:
- •?CrCL= ((140-age) x (weight in kg) x (72 x (serum creatinine in mg/dL)-1) (x 0.85 if female)
- •For patients not receiving therapeutic antico-agulation: international normalized ratio (INR) or activated partial thromboplastin time aPTT = 1.5 × ULN within 28 days prior to initiation of study treatment
- •For patients receiving therapeutic anticoagu-lation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment
- •9.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- •a.With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same perio
排除标准
- •1.Candidates for direct surgery: patients with single site easily resectable metastasis
- •2.Major surgical procedure or significant traumatic injury within 2 weeks prior to first dose of study drug treatment
- •3.Palliative radiotherapy within 14 days prior to initiation of study treatment
- •4.Active malignancy (other than BRAFV600 mutation-positive melanoma) or malignancy within 3 years prior to screening
- •5.A history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
- •6.History of clinically significant cardiac dysfunction,
- •7.Untreated or actively progressing CNS lesions (carcinomatous meningitis)
- •9.History of metastases to brain stem, midbrain, pons, or medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- •10.History of leptomeningeal metastatic disease
- •11.Anticipated use of any concomitant medication during or within 7 days prior to initiation of study treatment that is known to cause QT prolongation. Patients with regular amiodaron intake in the last 365 days cannot be included
- •12.Uncontrolled diabetes or symptomatic hyperglycemia
- •13.History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment
- •14.Pregnancy or lactation period or intention to become pregnant during the study.
- •15.Prior allogeneic stem cell or solid organ transplantation
- •16.History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •17.Active or history of autoimmune disease or immune deficiency (for details see 10.1.2.5 and Appendix 8).
- •18.Known clinically significant liver disease, including alcoholism, cirrhosis, fatty liver, and other inherited liver disease as well as active viral disease
- •19.Active tuberculosis
- •20.Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •21.Any Grade = 3 hemorrhage or bleeding event within 4 weeks prior to initiation of study treatment
- •22.History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to initiation of study treatment
- •23.Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) or any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or could jeopardize the safety of the patient and their compliance in the study
- •24.Signs or symptoms of clinically relevant infection and/or treatment with therapeutic systemic antibiotics within 2 weeks prior to initiation of study treatment
- •25.Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- •26.Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)
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