A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

Melanoma Clinical Trial

Official title:

GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00796445
• Other study ID #: 111482
• Secondary ID: 2008-002447-16
• Status: Terminated
• Phase: Phase 3
• Start date: December 1, 2008
• Est. completion date: January 27, 2016

Study information

• Verified date: February 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1351
• Est. completion date: January 27, 2016
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent signed.

• Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.

• The patient must have been surgically rendered free of disease before the randomization.

• Patient is = 18 years old at the time of signing the informed consent form.

• The patient's lymph node tumor shows expression of the MAGE-A3 gene.

• The patient has fully recovered from surgery.

• ECOG performance status of 0 or 1 at the time of randomization.

• The patient must have adequate organ functions as assessed by standard laboratory criteria.

• If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.

• In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Exclusion Criteria:

• The patient suffers from a mucosal or ocular melanoma.

• The patient has or has had any history of in-transit metastases

• The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.

• The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.

• Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.

• The patient has a history of autoimmune disease.

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

• The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.

• History of allergic disease or reactions likely to be exacerbated by any component of the treatments.

• 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.

• The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.

• The patient has an uncontrolled bleeding disorder.

• For female patients: the patient is pregnant or lactating.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• GSK 2132231A
IM solution, a course of 13 injections administered over 27 months
• Placebo
IM solution, a course of 13 injections administered over 27 months

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Cipolletti	Río Negro
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Brisbane	Queensland
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	East Melbourne	Victoria
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	North Sydney	New South Wales
Australia	GSK Investigational Site	Waratah	New South Wales
Australia	GSK Investigational Site	Westmead	New South Wales
Austria	GSK Investigational Site	Feldkirch
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Wels
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Wilrijk
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	São Paulo
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Hradec Kralove
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Praha 10
Czechia	GSK Investigational Site	Praha 2
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Besançon cedex
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Boulogne
France	GSK Investigational Site	Brest
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Grenoble
France	GSK Investigational Site	Le Mans
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Limoges cedex
France	GSK Investigational Site	Marseille Cedex 5
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Pierre-Bénite cedex
France	GSK Investigational Site	Poitiers
France	GSK Investigational Site	Reims
France	GSK Investigational Site	Rennes
France	GSK Investigational Site	Rouen
France	GSK Investigational Site	Saint-Etienne
France	GSK Investigational Site	Toulouse cedex 9
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Villejuif
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Buxtehude	Niedersachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Erfurt	Thueringen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Greifswald	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Homburg	Saarland
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oldenburg	Niedersachsen
Germany	GSK Investigational Site	Quedlinburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Regensburg	Bayern
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Ireland	GSK Investigational Site	Cork
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Galway
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Petach Tikva
Israel	GSK Investigational Site	Ramat Gan
Italy	GSK Investigational Site	Aviano (PN)	Friuli-Venezia-Giulia
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Meldola (FC)	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Siena	Toscana
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Rotterdam
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Wellington
Norway	GSK Investigational Site	Oslo
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Kraków
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Slupsk
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Romania	GSK Investigational Site	Baia Mare
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Craiova, Dolj
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Kursk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Omsk
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Stavropol
Serbia	GSK Investigational Site	Belgrad
Serbia	GSK Investigational Site	Belgrad
Serbia	GSK Investigational Site	Sremska Kamenica
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Pamplona
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Uppsala
Switzerland	GSK Investigational Site	Basel
Switzerland	GSK Investigational Site	Zürich
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan Hsien
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Krivoy Rog
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lviv
United Kingdom	GSK Investigational Site	Belfast, Northern Ireland
United Kingdom	GSK Investigational Site	Chelmsford	Essex
United Kingdom	GSK Investigational Site	Colchester
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Poole, Dorset
United Kingdom	GSK Investigational Site	Salisbury
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bedford	Texas
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fridley	Minnesota
United States	GSK Investigational Site	Grand Rapids	Michigan
United States	GSK Investigational Site	Hackensack	New Jersey
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Latham	New York
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Lubbock	Texas
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	Morristown	New Jersey
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orange Park	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis Park	Minnesota
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	Sayre	Pennsylvania
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Vancouver	Washington
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (2)

Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFN? Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15. — View Citation

Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).	At Final analysis (Month 30 = Year 2.5)
Primary	Disease Free Survival (DFS)	DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).	At follow-up analysis (up to Year 5)
Secondary	Overall Survival (OS)	Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.	At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Secondary	Disease-free Specific Survival (DFSS)	Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).	At Final analysis (Month 30 = Year 2.5)
Secondary	Distant Metastasis-free Survival (DMFS)	Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).	At Final analysis (Month 30 = Year 2.5)
Secondary	Health-related Quality of Life	The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.	At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence
Secondary	Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value	The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).	At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
Secondary	Anti-MAGE-A3 Antibody Geometric Mean Concentrations	Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.	At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary	Number of Subjects With Anti-MAGE-A3 Antibody Response	Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration = 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration = 2 fold the pre-treatment antibody concentration.	At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary	Number of Subjects With Abnormal Haematological and Biochemical Parameters	Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.	Within the 31-day (Days 0-30) post-treatment period
Secondary	Number of Subjects With Any Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	Within the 31-day (Days 0-30) follow-up period after treatment
Secondary	Number of Subjects With Any Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Day 0 up to study end (up to 5 years)
Secondary	Number of Subjects With Potential Immune-mediated Diseases (pIMDs)	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.	From Day 0 up to study end (up to 5 years)

External Links

•   IPD for this study will be made available via the Clinical Study Data Request site.