2024-511271-15-00已完成2 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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- 1. Objective response
研究概览
简要总结
To evaluate the efficacy of immunotherapy-based treatment combinations
研究设计
- 分配方式
- Randomized
- 主要目的
- Multiple Immunotherapy Based Treatments Combinations Study for Patients with Pancreatic cancer
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
1. Objective response
1. Objective response
次要结局
- 1. Progression free survival
- 2. Overall survival
- 3. Overall survival at specific timepoints
- 4. Duration of response
- 5. Disease control
- 6. Incidence, nature, and severity of adverse events and laboratory abnormalities
- 7. Change from baseline in vital signs and ECG parameters
- 8. Change from baseline in targeted clinical laboratory test results
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (3)
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