EUCTR2016-002062-31-GB进行中（未招募）1 期
A multicentre randomised phase III trial comparing pembrolizumab versus standard chemotherapy for advanced pre-treated malignant pleural mesothelioma - Pembrolizumab versus standard therapy in mesothelioma (PROMISE-meso)
ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 142 人开始时间: 2017年2月23日最近更新:
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
- 142
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
- •- Male and female patients aged 18 years and older
- •- Histologically confirmed malignant pleural mesothelioma (all subtypes are eligible)
- •- Progressing after or on previous platinum based chemotherapy.
- •- Availability of tumour tissue for translational research
- •- ECOG performance status 0-1 (patients who capable of all self-care)
- •- Life expectancy of at least 3 months
- •- Measurable or evaluable disease according to RECIST 1.1 criteria
- •- Adequate haematological function (Haemoglobin =90 g/L or =5.6 mmol/L; White Blood Cells =1.0 × 109/L; Lymphocytes =0.5 g/L; Absolute neutrophils count (ANC) =1.5 × 109/L; Platelet count =100 × 109/L)
- •- Adequate renal function (Creatinine =1.5 × ULN OR calculated creatinine clearance =40 mL/min)
- •- Adequate liver function (ALT and AST =2.5 × ULN; if the patient has liver metastases, ALT and AST must be =5 × ULN)
- •- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 35 days before randomisation (the test has to be repeated 72 hours before pembrolizumab treatment start).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 142
排除标准
- •- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •- Prior therapy with gemcitabine or vinorelbine.
- •- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to randomisation and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to randomisation. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
- •- Known or suspected hypersensitivity to pembrolizumab or any of its excipients.
- •- Known unstable or unresolved surgical or chemotherapy-related toxicity that would compromise the patient’s capacity to participate in the trial.
- •- Previous allogeneic tissue/solid organ transplant.
- •- Live vaccines within 30 days prior to first dose of pembrolizumab.
- •- Regular intake of immune-modulating drugs (such as interferon, methotrexate).
- •- History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- •- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or topical therapy (e.g., steroids) for psoriasis or eczema is not considered a form of systemic treatment.
- •- Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, or antifungal therapy.
- •- HIV infection.
- •- Known active hepatitis B or hepatitis C.
- •- Known history of active tuberculosis.
- •- Patients with diagnosed immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomisation.
- •- Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical condition that could affect the patient’s capacity to participate in the trial.
- •- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the trial or evaluation of the trial results.
- •- Women who are pregnant or in the period of lactation.
- •- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and up to 120 days following cessation of trial treatment.
研究者
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