2024-514979-17-04招募中2 期
PembrolizuMab beyond RECIST progression and oral metroNOmic cyclophosphamide in meTAstatic UROthelial cancer: a single-arm, monocentre, phase 2 trial: minotaURO study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Non progressive rate at 6 months
研究概览
简要总结
The primary endpoint is: non progressive rate at 6 months
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age = 18 years; • Histological diagnosis of urothelial carcinoma, Advanced or metastatic disease; • PD-L1 expression: PD-L1 determined by immunohistochemistry (IHC; Dako 22C3 pharmDx assay; Agilent Technologies) at a local laboratory, with expressions scored using the combined positive score (CPS); • Eastern Cooperative Oncology Group performance status (ECOG PS) =2; • Adequate hematologic, renal, and hepatic function; RECIST 1.1 measurable disease; • Ongoing Pembrolizumab, as clinically indicated (progression after platinum-based chemotherapy); • Progression disease according to RECIST criteria; Criteria for receiving ICIs beyond RECIST v1.1 progression are: clinical benefit assessed by investigator, stable performance status, tolerance of treatment and no need to deliver immediate intervention to prevent serious complication of progression; iUPD(immune unconfirmed progressive disease according to iRECIST criteria); which require radiological confirmation; Oligometastatic disease: minimal metastatic state in which patients have a low burden of metastatic disease with only a small number of metastatic sites at initial presentation of their illness; Written informed consent
排除标准
- •Condition requiring treatment with glucocorticoids (equivalent to >10 mg of prednisone daily); • Hyperprogression condiction definited as two-fold or greater increase in the tumor growth rate in terms of volume during immunotherapy or a time to treatment failure of less than 2 months or a greater than 50% increase in tumor burden in two diameters according to irRC compared with pre-immunotherapy imaging that was obtained within 2 months of the initiation of the immuno-oncology agent, or a greater than two fold increase in progression pace with one diameter or a two fold or greater increase in the tumor growth rate in one diameter on immunotherapy
结局指标
主要结局
Non progressive rate at 6 months
Non progressive rate at 6 months
次要结局
- • The secondary end points are: duration of response (DOR); disease control rate (DCR); time to progression (TTP); OS; safety. Exploratory Endpoints: To identify biomarkers in blood and tissue samples to evaluate the mechanism of immune-resistance (Immunogenicity of pembrolizumab given in combination with metronomic cyclophoshamide
研究者
Massimo Zeuli
Scientific
I.F.O. Istituti Fisioterapici Ospitalieri
研究点 (1)
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