Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Immunotherapeutic GSK2132231A
Intervention description: Administration by intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASCI (Antigen-Specific Cancer Immunotherapeutic); MAGE-A3; Malignant melanoma; Cancer immunotherapeutic

Summary:

      The clinical objective of this clinical trial is to examine the clinical activity in terms of
      tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A
      when given to patients with unresectable and progressive metastatic cutaneous melanoma. The
      safety of the treatment will also be assessed just as its immunogenicity in terms of the
      humoral and cellular immune response induced by the GSK2132231A immunotherapeutic.
      Translational research objectives are to assess the effects of the study treatment in terms
      of various biological variables.
    

Eligibility criteria:

        Inclusion Criteria:

          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 3 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, as assessed by standard laboratory criteria.

          9. 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 the entire study treatment period and for 2 months after completion
             of the treatment injection series.

         10. In the view of the investigator, the patient can and will comply with the requirements
             of the protocol.

        Exclusion Criteria:

          1. The patient has at any time received systemic (bio)-chemotherapy

          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.

          4. The patient has received any cancer immunotherapeutic containing a MAGE A3 antigen or
             any cancer immunotherapeutic for his/her metastatic disease.

          5. Use of any investigational or non-registered product (drug or vaccine) other than the
             study treatment 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

          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.