Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma

Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

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.

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.