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
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
- Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
研究概览
简要总结
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
详细描述
No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents.
Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal.
Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors.
The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.
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 malignant mesothelioma (MM)
- •Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
- •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
- •Not pregnant or nursing
- •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
- •Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or not compensated chronic heart disease in NYHA class II or more
- •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 of Tremelimumab
Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
干预措施: Tremelimumab (Drug)
结局指标
主要结局
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
时间窗: Weeks 24
The objective tumor response is defined as a confirmed complete response (CR) or partial response (PR) according to the modified RECIST criteria for pleural mesothelioma
次要结局
- Disease control rate(1 year)
- Progression free survival(1 year)
- Safety(2 years)
研究者
Michele Maio
Head of Medical Oncology and Immunotherapy, University Hospital of Siena
Azienda Ospedaliera Universitaria Senese