NCT04040231已完成1 期
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •Karnofsky performance status >/= 70%
- •Pathologic diagnosis of malignant pleural mesothelioma at MSK
- •Positive immunohistochemical staining for WT-1 within 60 days of treatment start
- •Patients must have received at least one prior course of pemetrexed-based chemotherapy
- •Patients of childbearing potential must have a negative serum pregnancy test within 24 hours of receiving the first treatment on the study (if female) and must be practicing an effective form of birth control for the entire duration of treatment (both females and males)
- •Has received and progressed or are refractory to pemetrexed based chemotherapy
- •Measurable or evaluable disease
- •Biochemical parameters: Total bilirubin < 1.5 mg/dl, AST and ALT < 3.0 x upper limits of normal, Creatinine < 1.5 x upper limits of normal
排除标准
- •Pregnant or lactating women
- •Prior receipt of checkpoint inhibition
- •Patients with known active hepatitis B or known active hepatitis C virus
- •Patients with a serious unstable medical illness or another active cancer
- •Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Autoimmune disease requiring treatment with systemic steroids in the past 2 years
- •Current use of systemic corticosteroids at doses greater than prednisone 10 mg daily or the equivalent
- •Patients with active pneumonitis
- •Hematologic parameters: Absolute neutrophil count >/= 1000/mcL
- •Platelet count <100,000
研究组 & 干预措施
Malignant Pleural Mesothelioma (MPM)
Experimental
Participants with previously treated Malignant Pleural Mesothelioma/MPM
干预措施: Galinpepimut-S (Biological)
Malignant Pleural Mesothelioma (MPM)
Experimental
Participants with previously treated Malignant Pleural Mesothelioma/MPM
干预措施: Nivolumab (Drug)
Malignant Pleural Mesothelioma (MPM)
Experimental
Participants with previously treated Malignant Pleural Mesothelioma/MPM
干预措施: Sargramostim (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: up to 24 months
A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
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