Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)
Intervention description: Up to 24 intramuscular administrations
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASCI; melanoma; tumor antigen; unresectable; progressive; NY-ESO-1; adult; cancer-testis antigen; Immunotherapy

Summary:

      The purpose of this study is to investigate the safety, immunogenicity and clinical activity
      of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients
      with non-operable and progressing metastatic cutaneous melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient with histologically proven, measurable metastatic cutaneous
             melanoma, and with documented progressive disease within the 12 weeks before the first
             administration of study treatment.

          -  Written informed consent for NY-ESO-1 expression screening and gene profiling on
             resected tumor tissue and for the complete study has been obtained from the patient
             prior to shipment of the sample for expression testing and prior to the performance of
             any other protocol-specific procedure.

          -  Patient is >= 18 years of age at the time of signature of the informed consent.

          -  The patient's tumor shows expression of NY-ESO-1, as determined by real-time
             quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis or any
             updated technique on fresh tissue sample(s).

          -  Eastern Cooperative Oncology Group performance status of 0 or 1.

          -  The patient has normal organ functions as shown by all of the following:

               -  Hemoglobin ≥ 12 g/dL

               -  Absolute leukocytes count ≥ 3.0 x 1000000000/L

               -  Absolute lymphocytes count ≥ 1.0 x 1000000000/L

               -  Platelets ≥ 100 x 1000000000/L

               -  Serum creatinine ≤ Upper Limit of Normal (ULN)

               -  Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome
                  for whom the limit is 2 x ULN)

               -  Lactate dehydrogenase ≤ ULN

               -  Aspartate aminotransferase ≤ 2 × ULN

               -  Alanine aminotransferase ≤ 2 × ULN

        These tests must be done no more than 3 weeks before the first ASCI administration.

          -  Female patients of non-childbearing potential may be enrolled in the study.

          -  Female patient of childbearing potential may be enrolled in the study, if the patient:

               -  has practiced adequate contraception for 30 days prior to first ASCI
                  administration, and

               -  has a negative pregnancy test at the specified study visits, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the ASCI administration series.

          -  In the view of the investigator, the patient can and will comply with the requirements
             of this protocol.

        Exclusion Criteria:

          -  The patient has at any time received systemic chemotherapy, biochemotherapy, small
             molecules or nti-CTLA-4 monoclonal antibody for metastatic disease.

          -  The patient is scheduled to receive any other anticancer treatments than those
             specified in the protocol, including but not limited to (bio-) chemotherapeutic,
             immunomodulating agents and radiotherapy.

          -  The patient received any cancer immunotherapy containing a NY-ESO-1 antigen or any
             cancer immunotherapy for his/her metastatic disease.

          -  The patient requires concomitant treatment with systemic corticosteroids, or any other
             immunosuppressive agents.

          -  Use of any investigational or non-registered product other than the ASCI within 30
             days preceding the first ASCI administration, or planned use during the study period.

          -  The patient has (had) 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 allergy to any component of the study investigational product or
             has a history of previous allergic reactions to vaccinations.

          -  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.

          -  The patient has a family history of congenital or hereditary immunodeficiency.

          -  The patient is known to be positive for the Human Immunodeficiency Virus.

          -  The patient has an uncontrolled bleeding disorder.

          -  The patient has a family history of congenital or hereditary immunodeficiency.

          -  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.

          -  For female patients: the patient is pregnant or lactating.