EUCTR2008-001301-42-BE进行中（未招募）不适用
An open Phase II study to assess the clinical activity and safety of recMAGE-A3 + AS15 cancer immunotherapeutic in patients with metastatic cutaneous melanoma, and to explore its immunogenic properties, including their relation to tumor infiltration, genomics and proteomics - MAGE3-AS15-MEL-004 (MET)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- 性别
- All
入选标准
- •1. The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:
- •–Stage III in transit, or
- •–Stage III unresectable, or
- •–Stage IV M1a.
- •2. There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
- •3. The patient presents at screening with at least three tumor lesions of diameter =0.5 mm.
- •4. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
- •5. The patient is >18 years of age at the time of signature of informed consent.
- •6. The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
- •7. The patient's ECOG performance status is 0 or 1.
- •8. The patient has normal organ functions
- •9. If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, 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 treatment administration series.
- •10. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. 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).
- •2. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
- •3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
- •[Note: The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease or topical steroids is permitted and does not count as fulfilment of this exclusion criterion.]
- •4. The patient has received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
- •[Note: Previous adjuvant treatment with a cancer immunotherapeutic containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least eight weeks before the first ASCI administration in the present study.]
- •5. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment(s) within the 30 days preceding the first dose of study treatment, or planned use during the study period.
- •6. 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.
- •7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- •8. The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease. [Patients with vitiligo are not excluded by this criterion.]
- •9. The patient has a family history of congenital or hereditary immunodeficiency.
- •10. The patient is known to be positive for the human immunodeficiency virus (HIV).
- •11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
- •12. 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.
- •13. For female patients: the patient is pregnant or lactating.
- •14. The patient has an uncontrolled bleeding disorder.
研究者
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