MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
Intervention description: IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic,; Melanoma,; Antigen-Specific Cancer Immunotherapeutic,; ASCI; MAGE-A3; tumor antigen,

Summary:

      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.
    

Eligibility criteria:

        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.