A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
Condition: Melanoma
MeSH terms: Melanoma
Intervention: GSK 2132231A; Placebo
Intervention description: IM solution, a course of 13 injections administered over 27 months; IM solution, a course of 13 injections administered over 27 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DERMA; Tumor antigen; Immunotherapeutic; Adjuvant cancer therapy; Melanoma; ASCI

Summary:

      The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic
      product GSK 2132231A in preventing disease relapse when given to melanoma patients, after
      surgical removal of their tumor.

      This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010.
      The impacted sections are outcome measures and entry criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent signed.

          -  Male or female patient with histologically proven stage IIIB or IIIC cutaneous
             melanoma presenting with macroscopic lymph node involvement suitable for surgery.

          -  The patient must have been surgically rendered free of disease before the
             randomization.

          -  Patient is ≥ 18 years old at the time of signing the informed consent form.

          -  The patient's lymph node tumor shows expression of the MAGE-A3 gene.

          -  The patient has fully recovered from surgery.

          -  ECOG performance status of 0 or 1 at the time of randomization.

          -  The patient must have adequate organ functions as assessed by standard laboratory
             criteria.

          -  If the patient is female, she must be of non-childbearing potential, or practice
             adequate contraception.

          -  In the opinion of the investigator, the patient can and will comply with all the
             requirements of the protocol.

        Exclusion Criteria:

          -  The patient suffers from a mucosal or ocular melanoma.

          -  The patient has or has had any history of in-transit metastases

          -  The patient has been treated or is scheduled to be treated with an adjuvant anticancer
             therapy after the surgery that qualifies the patient for inclusion in the present
             trial.

          -  The patient requires concomitant chronic treatment with systemic corticosteroids or
             any other immunosuppressive agents.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study treatment.

          -  The patient has a history of autoimmune disease.

          -  The patient has a family history of congenital or hereditary immunodeficiency.

          -  The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has
             another confirmed or suspected immunosuppressive or immunodeficient condition.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the treatments.

          -  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.

          -  The patient has previous or concomitant malignancies at other sites, except
             effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
             effectively treated malignancy that has been in remission for over 5 years and is
             highly likely to have been cured.

          -  The patient has an uncontrolled bleeding disorder.

          -  For female patients: the patient is pregnant or lactating.