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临床试验/EUCTR2017-000768-13-DE
EUCTR2017-000768-13-DE进行中（未招募）1 期

An open-label phase II multicenter study of vemurafenib (Zelboraf®) plus cobimetinib (Cotellic®) after radiosurgery in patients with active BRAF-V600-mutant melanoma brain metastases - RadioCoBRIM

Technische Universität Dresden0 个研究点目标入组 32 人开始时间: 2017年8月14日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
32
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 clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Signed informed consent
  • •Female and male patients = 18 years of age
  • •Histologically confirmed metastatic melanoma (stage IV, per AJCC staging), carrying BRAF V600-mutation
  • •Performed SRS 14 ±7 days before baseline using a harmonized protocol in patients with at least one measurable intracranial target lesion for which the following criteria are met:
  • •o Previously untreated (Lesions in previously irradiated area should not be selected)
  • •o Largest diameter of = 0.5 but = 4 cm as determined by contrast-enhanced MRI
  • •o = 10 brain metastases
  • •ECOG performance status 0 - 2
  • •Life expectancy = 12 weeks
  • •Adequate bone marrow function as indicated by the following:
  • •o ANC = 1500/µL
  • •o Platelets = 100,000/µL
  • •o Hemoglobin = 9 g/dL
  • •Adequate renal function, as indicated by creatinine = 1.5 x ULN
  • •Adequate liver function, as indicated by bilirubin < 1.5 x ULN and AST and ALT < 3 x ULN (documented liver metastases: AST and ALT < 5 x ULN)
  • •INR in normal range
  • •Able to swallow pills
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 24
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 8

排除标准

  • •Symptomatic brain metastases requiring immediate local interventions such as neurosurgery or radiosurgery
  • •Leptomeningeal disease (also synchronous with brain metastases)
  • •Prior therapy with BRAF or MEK inhibitors within 12 weeks prior to baseline visit (prior therapies for metastatic melanoma including chemo-, cytokine-, immuno-, biological and vaccine-therapy will be allowed). A period of at least 6 weeks must be observed between the last dose of ipilimumab and the first administration of the study treatments. Prior treatment with anti-programmed cell death (PD)-1 or anti-PD ligand 1 (PD-L1) is allowed.
  • •Prior whole brain irradiation (Patients with prior local therapy of brain metastases are eligible)
  • •Patients receiving therapeutic steroids are not stable on corticosteroids 2 weeks before SRS
  • •Active and uncontrolled infection
  • •Known HIV infection, or active HBV or HCV infection
  • •o Active HBV infection (chronic and acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening (past or resolved HBV infection, defined as negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible)
  • •o Active HCV infection, defined as positive HCV antibody test and positive HCV RNA test at screening
  • •Intracranial radiation therapy within 14 days prior to SRS
  • •Extracranial radiation therapy within the last 14 days prior to baseline visit
  • •Treatment with strong CYP3A4/5 inhibitors (e.g. ketoconazole) and inducers (e.g. phenytoin, carbamazepine). (anticonvulsant levetiracetam is allowed; patient should be stable on levetiracetam for 2 weeks)
  • •Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI v4.0) [NCI, 2009] Grade 2 or higher from previous anti-cancer therapy, except alopecia.
  • •Conditions that will interfere significantly with the absorption of drugs (e.g. Colitis ulcerosa)
  • •Inability to undergo MRI secondary to:
  • •o Claustrophobia
  • •o Gadolinium contrast allergy
  • •Previous malignancies active within the last 3 years, with the exception of locally curable cancers that have been treated to complete remission or untreated stage I chronic lymphoid leukemia.
  • •Unwillingness or inability to comply with study and follow-up procedures
  • •Known hypersensitivity to any of the excipients of cobimetinib and vemurafinib
  • •The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
  • •o St. John’s wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
  • •o Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
  • •Patient is included in another interventional trial
  • •Use of any investigational or non-registered product within 4 weeks prior to baseline visit
  • •Pregnant or lactating women
  • •History, risk factor or retinal pathology that increases the risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): evidence of retinal pathology that is considered a risk factor for RVO or CSR, or a history of retinal detachment, central serous chorioretinopathy or retinal vein thrombosis. The risk factors for RVO are listed below:
  • •oUncontrolled glaucoma with intraocular pressures > 21 mm Hg,
  • •oSerum cholesterol = Grade 2 (= 7.75 mmol/L),
  • •oHypertriglyceridemia = Grade 2 (= 3.42 mmol/L),
  • •Hyperglycemia (fasting) = Grade 2 (= 8.9 mmol/L).
  • •History of clinically significant cardiac dysfunction including:
  • •o Myocardia

研究者

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