EUCTR2015-003301-42-DE进行中（未招募）1 期
A Phase III open-label, multicenter trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma - Avelumab in Third-Line Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •?Male or female subjects aged = 18 years
- •?Subjects with histologically confirmed unresectable, recurrent, locally advanced or metastatic adenocarcinoma of the stomach or GEJ
- •?ECOG PS of 0 to 1 at trial entry
- •?Estimated life expectancy of more than 12 weeks
- •?Adequate hematological, hepatic and renal functions defined by the protocol
- •?Negative blood pregnancy test at Screening for women of childbearing potential.
- •?Highly effective contraception for both male and female subjects if the risk of conception exists
- •?Other protocol defined criteria could apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •?Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
- •?Concurrent anticancer treatment
- •?Major surgery
- •?Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <10 mg prednisone daily).
- •?All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
- •?Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
- •?Prior organ transplantation, including allogeneic stem-cell transplantation
- •?Significant acute or chronic infections
- •?Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •?Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- •?Persisting toxicity related to prior therapy except alopecia
- •?Neuropathy Grade > 3.
- •?Pregnancy or lactation
- •?Known alcohol or drug abuse
- •?History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
- •?Clinically significant (i.e., active) cardiovascular disease
- •?All other significant diseases might impair the subject’s tolerance of trial treatment
- •?Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
- •?Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
- •?Legal incapacity or limited legal capacity
- •? Subjects will be excluded from the treatment with irinotecan or paclitaxel monotherapy if administration of their chemotherapy would be inconsistent with the current local labeling (for example, in regard to contraindications, warnings/ precautions, or special provisions) for that chemotherapy. Investigators should check updated labeling via relavant websites before randomization
- •? Subjects should start treatment administration within 28 days after signing the informed consent form (ICF). Treatment administration will start within 4 days after the randomization call.
- •?Other protocol defined criteria could apply
研究者
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