CTIS2024-511271-15-00进行中（未招募）1 期
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus–Pancreatic Cancer) - WO39608
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 282
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed metastatic PDAC, For patients in Cohort 1: no prior systemic treatment for PDAC, For patients in Cohort 2: disease progression during administration of either 5-fluorouracil or gemcitabine-based first-line chemotherapy in the metastatic or locally advanced setting and, for patients treated in the locally advanced setting, occurrence of metastasis within 6 months after initiation of chemotherapy, Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing, Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Adequate hematologic and end-organ function test results
排除标准
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases., History of leptomeningeal disease, Active or history of autoimmune disease or immune deficiency, History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan, Positive HIV test at screening or at any time prior to screening, Active hepatitis B or C virus infection or active tuberculosis
研究者
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