A PHASE III, DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY OFATEZOLIZUMAB PLUS COBIMETINIB AND VEMURAFENIB VERSUS PLACEBO PLUSCOBIMETINIB AND VEMURAFENIB IN PREVIOUSLY UNTREATED BRAFV600 MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

F. Hoffman-La Roche Ltd.0 个研究点目标入组 500 人开始时间: 2016年10月25日最近更新: 2018年3月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 500

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 form
•- Women and men, age >= 18 years
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
•- Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma, as defined by the American Joint Committee on Cancer, 7th revised edition
•- Measurable disease, according to response evaluation criteria in solid tumours (RECIST), v1.1
•- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to initiation of study treatment, with the exception of amylase, lipase, and LDH where up to 28 days is acceptable (using central laboratory result)
•– Amylase and lipase >= 1.5 x ULN
•–Absolute neutrophil count (ANC) >= 1.5 × 10 exp9/L
•–Platelet count >= 100 × 10 exp9/L
•–Hemoglobin >= 9 gram (g)/decilitre (dL)
•–Albumin >= 2.5 g/dL
•–Bilirubin <= 1.5 × the upper limit of normal (ULN)
•- AST and ALT = 2.0×ULN
•- ALP = 2.5×ULN or, for patients with documented liver or bone metastases, ALP = 5×ULN
•-Patients with documented liver or bone metastases: alkaline phosphatase <= 5 × ULN
•–Serum creatinine <= 1.5 × ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockroft-Gault glomerular filtration rate estimation: (140-age) x (weight in kg) x (0.85 if female) 72 x (serum creatinine in milligram/dL)
•- Ability and capacity to comply with the study and follow-up procedure
•- For patients not receiving therapeutic anticoagulation: INR or aPTT = 1.5×ULN within 28 days prior to initiation of study treatment
•- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment
•- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per year during the treatment period and for 6 months after the last dose of study treatment
•- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

排除标准

•Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
•Traumatic injury within 2 weeks prior to initiation of study treatment
•Palliative radiotherapy within 14 days prior to initiation of study treatment
•Active malignancy (other than BRAFV600 mutation-positive melanoma) or malignancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the patient has been disease-free for at least 3 years
•History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
•History of clinically significant cardiac dysfunction, including the following:
•-Poorly controlled hypertension, defined as sustained, uncontrolled,
•nonepisodic baseline hypertension consistently above 159/99 mmHg despite
•optimal medical management
•Untreated or actively progressing CNS lesions (carcinomatous meningitis)
•History of metastases to brain stem, midbrain, pons, or medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm)
•History of leptomeningeal metastatic disease
•History of intracranial hemorrhage
•Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
•Anticipated use of any concomitant medication during or within 7 days prior to initiation of study treatment that is known to cause QT prolongation (which may lead to torsades de pointes)
•Any psychological, familial, sociological, or geographical condition that may hamper compliance with the protocol and follow-up after treatment discontinuation
•History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment
•Pregnant or breastfeeding, or intending to become pregnant during the study
•Prior allogeneic stem cell or solid organ transplantation
•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 CT scan
•History of autoimmune disease
•Known clinically significant liver disease, including alcoholism, cirrhosis, fatty liver, and other inherited liver disease as well as active viral disease
•Active tuberculosis
•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
•Signs or symptoms of infection within 2 weeks prior to initiation of study treatment
•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 may render the patient at high risk from treatment complications
•Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior

研究者

发起方

F. Hoffman-La Roche Ltd.

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