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)
- Conditions
- Adult patients with histologically proven, measurable metastatic cutaneous melanoma (stage III in transit or unresectable, or stage IV M1a), with documented progressive disease within the 12 weeks before the first administration of study treatment
- Registration Number
- EUCTR2008-001301-42-FR
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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, <0.5 mg/kg/day (absolute maximum 40 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method