Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
- 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.
- 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
- 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
- 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
- For female patients: the patient is pregnant or lactating.