MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Melanoma

Intervention / Treatment
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* Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A


Participation Criteria
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Eligibility Criteria
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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 excluded. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1203486A Group<br>Patients received 4 cycles of MAGE-A3 product as follows: Cycle 1: 6 doses, each given at a 2-week interval, Cycle 2: 6 doses, each given at a 3-week interval Cycle 3: 4 doses, each given at a 6-week interval Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides. | Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A<br>* IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | During the entire study, up to 2.5 years per patient | 
| The Rate of Objective Clinical Response. |  | At the time of analysis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Stable Disease. |  | At the time of analysis. | 
| The Rate of Mixed Response. |  | At the time of analysis. | 
| Time to Study Treatment Failure. |  | At the time of analysis. | 
| Progression-free Survival. |  | At the time of analysis. | 
| Progression-free Survival After Initial SPD. |  | At the time of analysis. | 
| Documentation of Any Toxicity. |  | During the entire study, up to 2.5 years per patient | 
| Immunogenicity at Defined Time Points. |  | At 13 defined time points. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic,, Melanoma,, Antigen-Specific Cancer Immunotherapeutic,, ASCI, MAGE-A3, tumor antigen,