EUCTR2015-004475-75-FR进行中（未招募）1 期
A randomized phase II study evaluating efficacy and safety of 2nd or 3rd line treatment by Nivolumab monotherapy or Nivolumab plus Ipilimumab, for unresectable Malignant Pleural Mesothelioma (MPM) patients - MAPS2
IFCT0 个研究点目标入组 114 人开始时间: 2016年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
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
- •1.Histologically proved diagnosis of unresectable malignant pleural Mesothelioma (MPM)
- •2.Available (archival and/or fresh) pathological samples for centralized PD-L1 expression assessment by immunohistochemistry
- •3.Age = 18 years old; male and female
- •4.ECOG Performance status 0-1
- •5.Weight loss < 10% during last 3 months
- •6.Life expectancy > 12 weeks
- •7.Documented progression of the MPM, assessed by computed tomography (CT) –Scan.
- •8.Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by CT-Scan and is suitable for repeated assessment using modified Response Evaluation Criteria in Solid Tumors [RECIST] for pleural mesothelioma (Byrne 2004; Therasse 2006).
- •9.Previous treatment by 1 or 2 systemic chemotherapy lines (1 line of chemotherapy considered if the patient received =2 cycles of this chemotherapy), including at least one line with pemetrexed in combination with platinum agent (i.e. gold standard chemotherapy in MPM; triplet including bevacizumab also accepted)
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1.Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
- •2.Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Ppatients with prostate adenocarcinoma diagnosed less than 5 years could be included in case of localized prostate cancer with good outcome according the Amico classification: = T2a and Gleason Score =6 and PSA blood level =10 ng/ml, and treated with curative intent (surgery or radiotherapy) without chemotherapy. Patients with history of solid tumors, including adenocarcinoma, treated with curative intent and without any evidence of disease >5 years can be included as well.
- •3.Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic patient
- •4.History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
- •5.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Intranasal/inhaled or topical steroids, and adrenal replacement steroid doses = 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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