A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Immunotherapeutic GSK2132231A
Intervention description: Intramuscular administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASCI; Melanoma; Immunotherapeutic; Tumor antigen; PREDICT

Summary:

      The objective of this study is to evaluate the clinical activity of the GSK2132231A
      immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma
      presenting with the predictive gene signature.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with histologically proven metastatic cutaneous melanoma that
             is measurable.

          -  Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can
             be included in the study, provided the disease is not amenable to curative treatment
             with surgery. In terms of the AJCC 2002 classification, this includes patients with
             unresectable stage III melanoma including in-transit metastases or patient with stage
             IV M1a melanoma.

          -  Written informed consent obtained from the patient prior to performance of any study
             specific procedure.

          -  Patient is >= 18 years at the time of signature of the informed consent form.

          -  The patient's tumor shows expression of MAGE-A3, as determined by RT-PCR analysis on a
             fresh tumor tissue sample obtained during the screening phase.

          -  Fresh tissue from the same lesion as used for MAGE-A3 expression testing must be
             available for the testing of the predictive gene signature.

          -  Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary
             MAGE-A3 and gene signature testing.

          -  Patient fully recovered from any previous intervention (i.e., biopsy).

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as
             assessed by standard laboratory criteria

          -  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 at least 30 days
             prior to registration in the trial, have a negative pregnancy test and continue such
             precautions during the entire study treatment period and for 2 months after completion
             of the injection series.

          -  In the opinion of the investigator, the patient can and will comply with the protocol
             requirements.

        Exclusion Criteria:

          -  Patients with unresectable stage IV M1b,c melanoma and patients with ocular and
             mucosal melanoma.

          -  The patient has at any time received any systemic anticancer treatment.

          -  Prior systemic treatment with an immunomodulator or loco-regional radiotherapy is
             permitted as prior adjuvant treatment provided that the last dose was administered at
             least 30 days before the registration into this trial;

          -  Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other
             than MAGE-A3 is allowed if the last administration took place at least 8 weeks before
             registration into the trial.

          -  Prior isolated limb perfusion is permitted provided that the last dose was
             administered at least 30 days before registration into this trial

          -  The patient is scheduled to receive any anti-cancer specific treatment, including
             radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.

          -  The patient requires concomitant chronic treatment (more than 7 consecutive days) with
             systemic corticosteroids, or any other immunosuppressive agents.

          -  The patient has a history of 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 Human Immunodeficiency Virus (HIV).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the ASCI treatment.

          -  The patient has previous or concomitant malignancies at other sites, except
             effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix and
             effectively treated malignancy that has been in remission for over 5 years and is
             highly likely to have been cured.

          -  The patient has psychiatric or addictive disorders

          -  The patient has an uncontrolled bleeding disorder.

          -  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.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study medication within the 30 days preceding the first investigational treatment
             injection or planned use during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the patient has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device). For female patients:
             the patient is pregnant or lactating.