This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
GSK Investigational Site
CABA, Buenos Aires, Argentina
GSK Investigational Site
Quilmes, Buenos Aires, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, Argentina
GSK Investigational Site
Athens, Greece
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: During the entire study, up to 2.5 years per patient
Number of Subjects With Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study, up to 2.5 years per patient
The Rate of Objective Clinical Response.
Time frame: At the time of analysis.
The Rate of Stable Disease.
Time frame: At the time of analysis.
The Rate of Mixed Response.
Time frame: At the time of analysis.
Time to Study Treatment Failure.
Time frame: At the time of analysis.
Progression-free Survival.
Time frame: At the time of analysis.
Progression-free Survival After Initial SPD.
Time frame: At the time of analysis.
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GSK Investigational Site
Athens, Greece
GSK Investigational Site
Oslo, Norway
Documentation of Any Toxicity.
Time frame: During the entire study, up to 2.5 years per patient
Immunogenicity at Defined Time Points.
Time frame: At 13 defined time points.