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临床试验/EUCTR2017-002887-42-DE
EUCTR2017-002887-42-DE进行中（未招募）1 期

Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN) - EBI

EORTC0 个研究点目标入组 270 人开始时间: 2018年3月19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）
发起方
EORTC
入组人数
270
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

  • •Histologically or cytologically confirmed unresectable stage III/ IV
  • •cutaneous or mucosal melanoma (unknown primary also allowed)
  • •Presence of BRAF V600E or V600K mutation in tumor tissue prior to
  • •enrolment as per local assessment
  • •Tumor tissue (FFPE) from an unresectable or metastatic site of disease
  • •must be provided for biomarker analyses. This can be an archived
  • •sample if obtained at maximum 3 months prior to randomization and if
  • •the patient did not receive treatment since then.
  • •Measurable disease per RECIST 1.1 criteria by computed tomography
  • •(CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis
  • •and brain CT/MRI performed within 28 days prior to randomization
  • •Patients = 18 years of age
  • •Eastern Cooperative Oncology Group (ECOG) performance status (PS)
  • •Patients must be able to swallow and retain oral tablets
  • •Adequate organ function within 14 days prior to randomization:
  • •Absolute neutrophil count (ANC) = 1.5 x 109/L (= 1500 per mm3)
  • •Lymphocyte count = 1.0 x 109/L (= 1000 per mm3)
  • •Platelet count = 100 x 109/L (= 100,000 per mm3)
  • •Hemoglobin = 9.0 g/dL (= 5.59 mmol/l)
  • •Total bilirubin = 1.5 x institutional upper limit of normal (ULN) or
  • •direct bilirubin = ULN for patients with total bilirubin levels > 1.5 x ULN.
  • •AST (SGOT)/ALT (SGPT) = 2.5 x ULN (< 5x ULN in case of liver
  • •metastases)
  • •Lipase < 2.0 x the ULN and no radiologic or clinical evidence of
  • •pancreatitis
  • •Serum phosphorus, total calcium, total magnesium and potassium
  • •within normal ranges as per local lab values; in case of small variation
  • •(+/-10%) in phosphorus, calcium or magnesium, the patient may be
  • •considered eligible and the decision will be left to the investigator
  • •Creatinine = 1.5 x ULN or calculated creatinine clearance = 60 mL/min
  • •for patient with creatinine levels > 1.5 x ULN (according to Cockroft-
  • •International Normalized Ratio (INR) or Prothrombin Time (PT) and
  • •Activated Partial Thromboplastin Time (aPTT) = 1.5 x ULN
  • •Note: patients receiving anticoagulant therapy (have to be shifted to low
  • •molecular weight heparin (LMWH) before treatment start; as warfarin
  • •and related 4-hydroxycoumarin-containing molecules are not permitted)
  • •are eligible if their PT or INR or PTT is within the recommended range
  • •for the desired level of anticoagulation.
  • •Patients with hyperthyroidism or hypothyroidism but that are stable on
  • •hormone replacement can be included.
  • •Adequate cardiac function:
  • •- left ventricular ejection fraction (LVEF) = 50% as determined by a
  • •multigated acquisition (MUGA) scan or echocardiogram,
  • •- 12-lead ECG. Single ECG should be obtained after the patient has been
  • •in a supine position for 5 minutes and recorded while the patient
  • •remains in that position on which QTcF must be <470 ms.
  • •Women of child bearing potential (WOCBP) must have a negative
  • •serum (preferred) or urine pregnancy test within 72 hours prior to
  • •registration.
  • •Note: women of childbearing potential are defined as premenopausal
  • 另有 9 项未显示

排除标准

  • •Uveal melanoma
  • •Any symptomatic brain or leptomeningeal disease. Subjects with brain metastases are eligible if these have been locally treated and there is no magnetic resonance imaging (MRI) evidence of progression 4 weeks
  • •after end of treatment. There must also be no requirement for
  • •immunosuppressive doses of systemic corticosteroids (> 10 mg/day
  • •prednisone equivalents) for at least 2 weeks prior to study drug
  • •administration.
  • •Any prior treatment for advanced disease including treatment with an
  • •anti-programmed death receptor-1 (PD-1), anti-programmed death-1
  • •ligand-1 (PD-L1), anti-PD-L2, anti-cytotoxic T lymphocyte associated
  • •antigen-4 (anti-CTLA-4) antibody, anti-LAG-3, anti-TIM-3, anti-IDO, etc
  • •or BRAF or MEK inhibitors.
  • •History of hypersensitivity to study drugs or any excipient
  • •Prior adjuvant melanoma therapy with IFN, anti-PD1, anti-PDL1 or
  • •anti-CTLA-4 or any other systemic treatment is permitted if completed at least 6 months prior to randomization and all related adverse events have returned to grade = 1.
  • •Concomitant administration of strong inducers and inhibitors of P-gp,
  • •glucuronidation, CYP3A4
  • •Concomitant anticoagulation at therapeutic doses with oral
  • •anticoagulants
  • •Live vaccines within 30 days prior to the first dose of study therapy.
  • •Current participation or treatment with other investigational agent or
  • •use of an investigational device within 4 weeks of the first dose of study
  • •Child-Pugh B/C and patients with history of acute or chronic pancreatitis
  • •Known history or current evidence of active Hepatitis B or C
  • •History of Human Immunodeficiency Virus (HIV)
  • •Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 2 weeks prior to the first dose of
  • •study treatment
  • •- Corticosteroid use as premedication for IV contrast allergies/reactions
  • •- Conditions requiring systemic treatment with <10 mg daily prednisone equivalents or equivalent doses of any other corticosteroid are allowed
  • •- History of interstitial lung disease (ILD) OR pneumonitis (other than
  • •chronic obstructive pulmonary disease (COPD) exacerbation) that has required oral or IV steroids are not allowed
  • •Active autoimmune disease that has required systemic treatment in
  • •past 2 years. Replacement therapy is not considered a form of systemic
  • •treatment and is allowed
  • •Autoimmune paraneoplastic syndrome requiring immunosuppressive
  • •or dedicated treatment. A specific attention should be given in order to
  • •detect any minor myasthenia signs at enrolment
  • •History of any other hematologic or primary solid tumor malignancy,
  • •unless in remission for at least 5 years. A patient with a history of
  • •completely resected non-melanoma skin cancer or successfully treated
  • •in situ carcinoma are eligible
  • •Previous allogeneic tissue/solid organ transplant
  • •Active infection requiring therapy
  • •Major surgery or trauma within 12 weeks prior to first dose of
  • •treatment or presence of any non-healing wound.
  • •Minor surgery within 28 days before randomization with complete
  • •wound healing at least 10 days before randomization is permitted.
  • •Any anticancer treatment within 4 weeks before randomization
  • •Patients with clinically relevant ongoing complications from prior
  • •anticancer therapies.
  • •Severe or uncontrolled systemic disease or any concurrent condition
  • 另有 3 项未显示

研究者

发起方
EORTC

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