CTRI/2019/04/018775尚未招募2 期
A Phase 1b/2 Open-label Study with randomization in Phase 2 of IMU-131 HER2/neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients with HER2/neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- To evaluate the clinical efficacy of IMU-131 plus chemotherapy
研究概览
简要总结
Phase 2 is an open-label, randomized, multicenter study designed to assess the clinical activity, immunogenicity, safety and tolerability of IMU-131. The length of Phase 2 will be approximately 22 months: 15 months’ recruitment and an estimated 22 months’ follow-up from initiation of randomization to realization of the required number of deaths. It is anticipated that an additional 3 months will be required to complete the analyses following realization of the last required death.
Please be informed that Moldova ( Country ) is also participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional local and national guidelines
- •Age more than and equal to 20 years old
- •Life expectancy of at least 12 weeks
- •No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0
- •HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization FISH] or chromogenic in situ hybridization [CISH]).
- •Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]) may be included in Phase 1b with agreement of Imugene Limited
- •ECOG performance status 0–2
- •At least one measurable lesion as defined by RECIST 1.1 criteria.
- •Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited
- •Adequate left ventricular ejection function at baseline defined as LVEF > 50% by echocardiogram or MUGA scan (Multi Gated Acquisition Scan)
- •Adequate hematologic function absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL;
- •Adequate renal function (creatinine ≤ 1.5 x laboratory ULN
- •Willing and able to comply with scheduled visits treatment plan laboratory tests and other study procedures
- •Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment .
- •A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •Previous treatment with trastuzumab or any other HER2/neu targeting antibody or agent
- •Continuous systemic treatment with either corticosteroids (Greater than 10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
- •Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease
- •Prior organ transplant
- •Patient not considered a candidate for 5-FU, capecitabine,cisplatin or oxaliplatin chemotherapy;
- •History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart disease;
- •If on warfarin (Coumadin®) or other vitamin K antagonists;
- •Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin
- •History of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
- •Active infection requiring IV antibiotics;
- •Positive for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA] qualitative) infection;
- •Pregnant or lactating females;
- •Major surgery within 4 weeks prior to study entry.
- •Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
- •Has received a live-virus vaccination within 4 weeks of first study vaccination.
- •Seasonal flu vaccines that do not contain live virus are permitted;
- •Current or recent (within 4 weeks of first IMU-131 vaccination) treatment with another investigational drug or participation in another investigational study.
- •Phase 2: Patients with a known diphtheria toxoid hypersensitivity.
结局指标
主要结局
To evaluate the clinical efficacy of IMU-131 plus chemotherapy
时间窗: 22 Months
compared to chemotherapy alone based on overall survival (OS).
时间窗: 22 Months
次要结局
- To evaluate other efficacy measures of IMU-131 plus(chemotherapy compared to chemotherapy alone including)
研究者
研究点 (12)
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