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GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

In order to achieve the target enrolment of 51 gene signature (GS) positive patients, it is
planned to enrol approximately 110 patients (both GS positive and negative).

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival rate of patients with the predictive gene signature

Outcome Time Frame:

1 year after the registration of the last patient with the predictive gene signature

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Ireland: Irish Medicines Board

Study ID:




Start Date:

August 2009

Completion Date:

June 2016

Related Keywords:

  • Melanoma
  • ASCI
  • Melanoma
  • Immunotherapeutic
  • Tumor antigen
  • Melanoma



GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Seattle, Washington  98133