EUCTR2016-001859-43-PL进行中（未招募）1 期
A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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 subjects (over 18 years of age).
- •-) Histologically proven diagnosis of MPM, thoracoscopy is highly recommended.
- •-) Advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy). Subjects that refuse potentially curative surgery are ineligible
- •-) Available (archival and/or fresh) pathological samples for centralized PD-L1 IHC testing during the screening
- •period. Subjects cannot be randomized until the tumor tissue for PD-L1 testing has been received at the Central
- •Lab, however, the result of the testing is not required prior to randomization. Subjects can initiate therapy before the result of PD-L1 testing is available.
- •-) Prior palliative radiotherapy is acceptable, but at least 14 days must have passed since the administration of the
- •radiotherapy and all signs of toxicity must have remitted.
- •- ECOG Performance Status of 0-1.
- •-) Measurable disease, defined as at least 1 lesion measured in up to two positions at three separate levels on transverse cuts of CT scan that is suitable for repeated assessment using adapted modified Response Evaluation Criteria in Solid Tumors [m-RECIST] for pleural mesothelioma
- •-) Adequate hematological, renal and hepatic functions
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •-) Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
- •-) Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within
- •the 3 months before inclusion, and asymptomatic. In addition, subjects must be either off corticosteroids, or on a
- •stable or decreasing dose of less or equal to 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization,
- •-) Prior treatment with adjuvant or neoadjuvant chemotherapy; radical pleuropneumonectomy with or without intensity modulated radiotherapy, or non-palliative RT
- •-) Prior intraoperative or intracavitary chemotherapy for pleural mesothelioma
- •-) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •-) History of chronic inflammatory or autoimmune disease
- •-) Concurrent or prior malignancy requiring or anticipated to require concurrent intervention
- •-) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of
- •suspected drug-related pulmonary toxicity.
研究者
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