NCT00706238终止2 期
Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
研究概览
简要总结
This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.
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
- •Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment.
- •Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
- •Patient is >= 18 years of age at the time of signature of the informed consent.
- •The patient's tumor shows expression of MAGE-A3 gene
- •ECOG performance status of 0 or
- •The patient has normal organ functions
- •If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
- •In the view of the investigator, the patient can and will comply with the requirements of the protocol.
排除标准
- •The patient has at any time received systemic (bio-)chemotherapy (except for isolated limb perfusion, as long as this was performed at least 4 weeks before first study treatment administration).
- •The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
- •The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
- •The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
- •The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first ASCI injection or it is planned that (s)he will receive such a drug during the study period.
- •The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
- •History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- •The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- •The patient has a family history of congenital or hereditary immunodeficiency.
- •The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
- •The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
- •The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •For female patients: the patient is pregnant or lactating.
结局指标
主要结局
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
时间窗: During the entire study, up to 2.5 years per patient
The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Number of Subjects With Any Serious Adverse Events (SAEs).
时间窗: During the entire study, up to 2.5 years per patient
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
The Rate of Objective Clinical Response.
时间窗: At the time of analysis.
次要结局
- Documentation of Any Toxicity.(During the entire study, up to 2.5 years per patient)
- Immunogenicity at Defined Time Points.(At 13 defined time points.)
- Progression-free Survival.(At the time of analysis.)
- Progression-free Survival After Initial SPD.(At the time of analysis.)
- Time to Study Treatment Failure.(At the time of analysis.)
- The Rate of Stable Disease.(At the time of analysis.)
- The Rate of Mixed Response.(At the time of analysis.)
研究者
研究点 (7)
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