A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Immunotherapeutic GSK2132231A; Dacarbazine
Intervention description: Intramuscular administration; Intravenous administration Chemotherapy
Intervention MeSH terms: Dacarbazine; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASCI; Dacarbazine; Cancer immunotherapeutic; MAGE-A3; Malignant melanoma

Summary:

      The purpose of this clinical trial is to find out how successfully, patients with progressive
      metastatic cutaneous melanoma, are able to develop an immune response to injections with the
      immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate
      the safety of this combination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patient with histologically proven, measurable metastatic cutaneous
             melanoma

          2. Written informed consent has been obtained from the patient before the performance of
             any protocol-specific procedure.

          3. Patient is >= 18 years of age at the time of signature of the Informed Consent.

          4. The patient's tumor shows expression of MAGE-A3 antigen, detected by
             Reverse-Transcription Polymerase Chain Reaction (RT-PCR).

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          6. The patient has normal organ functions.

          7. 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 the study treatment period and for 2 months after completion of
             the treatment administration series.

          8. 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 other anticancer treatments than those
             specified in the protocol, including but not limited to (bio)-chemotherapy,
             immunomodulating agents and radiotherapy.

          3. The patient requires concomitant treatment with systemic corticosteroids, or any other
             immunosuppressive agents.

          4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any
             cancer immunotherapeutic for his/her metastatic disease.

          5. The patient has received any investigational or non-registered drug or vaccine other
             than the study medication within the 30 days preceding the first dose of study
             treatment, or plans to receive such a drug 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, multiple sclerosis,
             lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.

          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 trial 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.

         14. The patient has an uncontrolled bleeding disorder.