EUCTR2008-001918-25-FR进行中（未招募）1 期
An open Phase I/II study of immunization with the recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic in association with dacarbazine in patients with MAGE-A3 positive unresectable and progressive metastatic cutaneous melanoma - MAGE3-AS15-MEL-002 (MET-chemo)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma.
- •According to the American Joint Committee on Cancer 2002 classification, all melanoma patients with stage IV M1b and stage IV M1c with serum lactate dehydrogenase (LDH) <= 1.5 Upper Normal Limit and no involvement of the central nervous system (CNS) are candidates for inclusion.
- •2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. Note: Procedures performed before obtaining this informed consent and that are part of standard institution practices or of another clinical research study are accepted provided protocol intervals are observed.
- •3. Patient is >= 18 years of age at the time of signature of the Informed Consent.
- •4. The patient’s tumor shows expression of MAGE-A3 antigen, detected by Reverse-Transcription Polymerase Chain Reaction (RT-PCR). A tumor biopsy performed in the context of institution standard practice or another research study may be used for the MAGE-A3 testing (or the use of the result of the MAGE-A3 testing) provided this biopsy was preserved in RNAlater, was taken no more than 12 weeks before the first administration of study treatment and after obtention of the Sponsor’s agreement.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. The patient has normal organ functions
- •7. 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.
- •8. In the view of the investigator, the patient can and will comply with all the study procedures
- •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 30
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 the
- •first study treatment administration).
- •2. The patient is scheduled to receive any other anticancer treatments than those
- •specified in the protocol, including but not limited to (bio-)chemotherapeutic,
- •immunomodulating agents and radiotherapy.
- •3. The patient requires concomitant treatment with systemic corticosteroids, or any
- •other immunosuppressive agents.
- •The use of prednisone, or equivalent, < 0.125 mg/kg/day (absolute maximum
- •10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease
- •(COPD), or topical steroids is permitted.
- •4. The patient 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 8 weeks before the first study treatment administration.
- •5. The patient has received any investigational or non-registered drug or vaccine other
- •than the study medication within the 30 days preceding the first dose of study
- •treatment, or plans to receive such a drug 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, multiple sclerosis,
- •lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- •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 trial 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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