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Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma, MAGE-A3-positive Unresectable and Progressive Metastatic Cutaneous Melanoma

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Trial Information

Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

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 has been obtained from the patient before the performance of
any 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 MAGE-A3 gene

- ECOG performance status of 0 or 1.

- The patient has normal organ functions

- 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 study treatment period and for 2 months after completion of
the injection series.

- In the view of the investigator, the patient can and will comply with the
requirements of the protocol.

Exclusion Criteria:

- The patient has at any time received systemic (bio-)chemotherapy (except for isolated
limb perfusion, as long as this was performed at least 4 weeks before first study
treatment administration).

- The patient is scheduled to receive any anti-cancer specific treatment, including
radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.

- The patient requires concomitant treatment with systemic corticosteroids, or any
other immunosuppressive agents.

- The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any
cancer immunotherapeutic for his/her metastatic disease.

- The patient has received any investigational or non-registered drug or vaccine other
than the study medication within the 30 days preceding the first ASCI injection or it
is planned that (s)he will receive such a drug during the study period.

- 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.

- History of allergic disease or reactions likely to be exacerbated by any component of
the study investigational product.

- The patient has an autoimmune disease such as, but not limited to, multiple
sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not

- The patient has a family history of congenital or hereditary immunodeficiency.

- The patient is known to be positive for the Human Immunodeficiency Virus (HIV).

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of ASCI-related grade 3 / 4 adverse events (CTCAE version 3 criteria)

Outcome Time Frame:

During the whole study.

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Norway: Norwegian Medicines Agency

Study ID:




Start Date:

September 2008

Completion Date:

January 2011

Related Keywords:

  • Melanoma
  • MAGE-A3-positive Unresectable and Progressive Metastatic Cutaneous Melanoma
  • metastatic,
  • Melanoma,
  • Antigen-Specific Cancer Immunotherapeutic,
  • ASCI
  • MAGE-A3
  • tumor antigen,
  • Melanoma
  • Skin Neoplasms