An open Phase II study of immunization with the recMAGE-A3 + AS01B Antigen-Specific Cancer Immunotherapeutic in patients with MAGE-A3-positive unresectable and progressive metastatic cutaneous melanoma. - MAGE3-AS01B-MEL-001 (MET)
- Conditions
- MAGE-A3-positive unresectable and progressive metastatic cutaneous melanoma.
- Registration Number
- EUCTR2007-005203-18-GR
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
1. 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.
2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
3. Patient is 18 years or older at the time of signature of the informed consent.
4. The patient’s tumor shows expression of MAGE-A3 gene.
5. ECOG performance status of 0 or 1.
6. The patient has normal organ functions shown by the lab values.
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 injection series.
8. 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.
The use of prednisone, or equivalent, less than 0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for 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 eight weeks before the first ASCI administration in the present study.
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 ASCI injection or it is planned that (s)he will 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The safety and clinical activity of recMAGE-A3 + AS01B in patients with MAGE-A3-positive metastatic cutaneous melanoma.;Secondary Objective: To evaluate and characterize other clinical indicators of clinical activity, indicators of biological activity and other indicators of safety.;Primary end point(s): • Safety of the ASCI injections assessed in terms of the:<br> Occurrence of serious adverse events during the study. <br> Occurrence of ASCI-related grade 3 / 4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 .<br><br>• Clinical activity: the rate of objective clinical response (CR or PR)<br>
- Secondary Outcome Measures
Name Time Method