MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Pati... | NCT00706238

ID	Type	Description	Link
2007-005203-18	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK1203486A Group	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A	Biological	IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

Outcomes Module

Primary Outcomes

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.

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.

Eligibility Module

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 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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		CABA	Buenos Aires	C1425DTG	Argentina
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK1203486A Group	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	GSK1203486A Group	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.

Units	Counts
Participants	BG0005

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.

Posted

Count of Participants

Participants

During the entire study, up to 2.5 years per patient

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG0005

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

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.

The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.

Posted

Count of Participants

Participants

During the entire study, up to 2.5 years per patient

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Primary

The Rate of Objective Clinical Response.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

The Rate of Stable Disease.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

The Rate of Mixed Response.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

Time to Study Treatment Failure.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival After Initial SPD.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At the time of analysis.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

Documentation of Any Toxicity.

As the study was terminated before the end of recruitment, data was not collected.

Posted

During the entire study, up to 2.5 years per patient

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Secondary

Immunogenicity at Defined Time Points.

As the study was terminated before the end of recruitment, data was not collected.

Posted

At 13 defined time points.

ID	Title	Description
OG000	GSK1203486A Group	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK1203486A Group	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.	0	5	1	5	5	5

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Inflammation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Injection site pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected5 at risk
Injection site reaction	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected5 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Pain in extremity	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected5 at risk

ID	Term
D008545	Melanoma
D009362	Neoplasm Metastasis

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms