MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
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.
Inclusion Criteria:

 -  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 1.

 -  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.

 Exclusion Criteria:

 -  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.