A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- To determine the objective response
研究概览
简要总结
RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.
PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.
详细描述
Primary endpoint:
- To assess the rate of objective clinical complete response (CR) or partial response (PR)
Secondary endpoints:
- To define toxicity profile according to NCI CT-CAE V. 3
- To assess the overall survival (OS)
- To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria
- To assess the progression-free survival in treated patients according to modified Recist criteria
- To evaluate qualitative and quantitative changes in cellular and humoral immune responses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed MM
- •Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
- •Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (modified RECIST criteria)
- •Disease not amenable to curative surgery
- •No known brain metastasis
- •Age 18 and over
- •Performance status 0-2
- •Life expectancy > 12 weeks
- •Adequate hematologic, hepatic and renal function
- •Platelet count > 75000/mm3
- •Absolute granulocyte count > 1000/mm3
- •Hemoglobin > 9 g/dL
- •Bilirubin total < 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dl
- •AST and ALT < 2.5 x ULN ( < 5 x ULN if documented liver metastasis are present)
- •Creatinine level < 2mg/dl or calculated creatinine clearance > 60 mL/min as determined by the Cockcroft Gault equation.
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution
排除标准
- •Symptomatic chronic inflammatory or autoimmune disease
- •Active hepatitis B or C
- •Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents
- •Clinically relevant cardiovascular disease
- •History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
- •Uncontrolled active infections
- •Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
- •History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years
研究组 & 干预措施
single arm with Tremelimumab
Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
干预措施: Tremelimumab (Drug)
结局指标
主要结局
To determine the objective response
时间窗: Weeks 24
The objective response is defined as a confirmed complete response (CR), or partial response (PR) according to the modified RECIST Criteria for pleural mesothelioma and the immune-related (ir) Response Criteria
次要结局
- Disease control rate (DCR)(1 year)
- Safety(3 years)
- Progression free survival(1 years)
研究者
Michele Maio
Head of Medical Oncology and Immunotherapy Unit
Azienda Ospedaliera Universitaria Senese