EUCTR2012-003524-21-NL进行中（未招募）不适用
A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 564
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
- •Subjects must meet all of the following criteria:
- •- Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma. Disease not amenable to curative surgery;
- •- Age 18 and over at the time of consent;
- •- ECOG Performance status 0-1;
- •- Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with a platinum agent;
- •- Recovered from all toxicities associated with prior treatment
- •- Measurable disease
- •- Adequate bone marrow, hepatic, and renal function
- •- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C.
- •- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations;
- •- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product;
- •- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 post last dose.
- •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 188
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 376
排除标准
- •Any of the following would exclude the subject from participation in the study:
- •- Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma;
- •- Received any prior monoclonal antibody against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
- •- History of chronic inflammatory or autoimmune disease;
- •- Active, untreated central nervous system (CNS) metastasis;
- •- History of other malignancy unless the subject has been disease-free for at least 3 years. Non-invasive cancer history (such as carcinoma in situ [CIS] that has been resected) is allowed;
- •- Pregnant or breast feeding at time of consent;
- •- Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;
- •- Active or history of diverticulitis. Note that diverticulosis is permitted;
- •- Active or history of inflammatory bowel disease (eg, colitis,
- •Crohn's), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosis or Wegener's granulomatosis;
- •- History of sarcoidosis syndrome;
- •- Currently receiving systemic corticosteroids or other
- •immunosuppressive medications;
- •- Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment;
- •- The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 2 weeks prior to randomization;
- •- Any unresolved toxicity from previous anticancer therapy;
- •- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
- •- Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks (participation in the survival follow-up period of a study is not an exclusion criterion);
- •- Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals.
研究者
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