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

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

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.

Study Overview

• Status: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Drug: GSK 2132231A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1351
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1050AAK
      • GSK Investigational Site
  • Río Negro
    • Cipolletti, Río Negro, Argentina, R8324EMB
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • GSK Investigational Site
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2060
      • GSK Investigational Site
    • North Sydney, New South Wales, Australia, 2060
      • GSK Investigational Site
    • Waratah, New South Wales, Australia, 2298
      • GSK Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • GSK Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • GSK Investigational Site
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • GSK Investigational Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • GSK Investigational Site
    • Heidelberg, Victoria, Australia, 3084
      • GSK Investigational Site
• Austria
  • Feldkirch, Austria, A-6800
    • GSK Investigational Site
  • Graz, Austria, A-8036
    • GSK Investigational Site
  • Linz, Austria, A-4010
    • GSK Investigational Site
  • Salzburg, Austria, A-5020
    • GSK Investigational Site
  • Wels, Austria, A-4600
    • GSK Investigational Site
  • Wien, Austria, A-1090
    • GSK Investigational Site
  • Wien, Austria, A-1030
    • GSK Investigational Site
  • Wien, Austria, A-1220
    • GSK Investigational Site
• Belgium
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Bruxelles, Belgium, 1070
    • GSK Investigational Site
  • Bruxelles, Belgium, 1180
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
  • Wilrijk, Belgium, 2610
    • GSK Investigational Site
• Brazil
  • São Paulo, Brazil, 03102-002
    • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30.140-001
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • GSK Investigational Site
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • GSK Investigational Site
  • Sofia, Bulgaria, 1756
    • GSK Investigational Site
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • GSK Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 656 53
    • GSK Investigational Site
  • Hradec Kralove, Czechia, 500 05
    • GSK Investigational Site
  • Ostrava, Czechia, 708 52
    • GSK Investigational Site
  • Praha 10, Czechia, 100 34
    • GSK Investigational Site
  • Praha 2, Czechia, 128 08
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13419
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• France
  • Besançon cedex, France, 25030
    • GSK Investigational Site
  • Bordeaux, France, 33075
    • GSK Investigational Site
  • Boulogne, France, 92104
    • GSK Investigational Site
  • Brest, France, 29609
    • GSK Investigational Site
  • Dijon, France, 21079
    • GSK Investigational Site
  • Grenoble, France, 38043
    • GSK Investigational Site
  • Le Mans, France, 72000
    • GSK Investigational Site
  • Lille, France, 59037
    • GSK Investigational Site
  • Limoges cedex, France, 87042
    • GSK Investigational Site
  • Marseille Cedex 5, France, 13385
    • GSK Investigational Site
  • Montpellier, France, 34295
    • GSK Investigational Site
  • Nantes, France, 44093
    • GSK Investigational Site
  • Nice, France, 06202
    • GSK Investigational Site
  • Paris, France, 75018
    • GSK Investigational Site
  • Paris, France, 75006
    • GSK Investigational Site
  • Paris Cedex 10, France, 75475
    • GSK Investigational Site
  • Pierre-Bénite cedex, France, 69495
    • GSK Investigational Site
  • Poitiers, France, 86021
    • GSK Investigational Site
  • Reims, France, 51092
    • GSK Investigational Site
  • Rennes, France, 35042
    • GSK Investigational Site
  • Rouen, France, 76031
    • GSK Investigational Site
  • Saint-Etienne, France, 42055
    • GSK Investigational Site
  • Toulouse cedex 9, France, 31059
    • GSK Investigational Site
  • Tours, France, 37044
    • GSK Investigational Site
  • Villejuif, France, 94805
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 10249
    • GSK Investigational Site
  • Berlin, Germany, 13585
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79104
      • GSK Investigational Site
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • GSK Investigational Site
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • GSK Investigational Site
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80802
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80337
      • GSK Investigational Site
    • Nuernberg, Bayern, Germany, 90419
      • GSK Investigational Site
    • Regensburg, Bayern, Germany, 93053
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97080
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • GSK Investigational Site
    • Kassel, Hessen, Germany, 34125
      • GSK Investigational Site
    • Marburg, Hessen, Germany, 35033
      • GSK Investigational Site
    • Wiesbaden, Hessen, Germany, 65191
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • GSK Investigational Site
  • Niedersachsen
    • Buxtehude, Niedersachsen, Germany, 21614
      • GSK Investigational Site
    • Hannover, Niedersachsen, Germany, 30625
      • GSK Investigational Site
    • Oldenburg, Niedersachsen, Germany, 26133
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • GSK Investigational Site
    • Minden, Nordrhein-Westfalen, Germany, 32429
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
      • GSK Investigational Site
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • GSK Investigational Site
    • Quedlinburg, Sachsen-Anhalt, Germany, 06484
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • GSK Investigational Site
    • Luebeck, Schleswig-Holstein, Germany, 23538
      • GSK Investigational Site
  • Thueringen
    • Erfurt, Thueringen, Germany, 99089
      • GSK Investigational Site
    • Jena, Thueringen, Germany, 07740
      • GSK Investigational Site
• Greece
  • Athens, Greece, 11527
    • GSK Investigational Site
  • Athens, Greece, 185 47
    • GSK Investigational Site
• Ireland
  • Cork, Ireland
    • GSK Investigational Site
  • Dublin, Ireland, 8
    • GSK Investigational Site
  • Dublin, Ireland, 9
    • GSK Investigational Site
  • Dublin, Ireland, 4
    • GSK Investigational Site
  • Dublin, Ireland, 7
    • GSK Investigational Site
  • Galway, Ireland, Co Galway
    • GSK Investigational Site
• Israel
  • Haifa, Israel, 31096
    • GSK Investigational Site
  • Petach Tikva, Israel, 49100
    • GSK Investigational Site
  • Ramat Gan, Israel, 52621
    • GSK Investigational Site
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
  • Emilia-Romagna
    • Meldola (FC), Emilia-Romagna, Italy, 47014
      • GSK Investigational Site
    • Modena, Emilia-Romagna, Italy, 41124
      • GSK Investigational Site
  • Friuli-Venezia-Giulia
    • Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00144
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20141
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56125
      • GSK Investigational Site
    • Siena, Toscana, Italy, 53100
      • GSK Investigational Site
  • Veneto
    • Padova, Veneto, Italy, 35128
      • GSK Investigational Site
• Japan
  • Shizuoka, Japan, 411-8777
    • GSK Investigational Site
  • Tokyo, Japan, 104-0045
    • GSK Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 05505
    • GSK Investigational Site
• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • GSK Investigational Site
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3075 EA
    • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 0622
    • GSK Investigational Site
  • Christchurch, New Zealand, 8011
    • GSK Investigational Site
  • Wellington, New Zealand, 6021
    • GSK Investigational Site
• Norway
  • Oslo, Norway, 0310
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • GSK Investigational Site
  • Gdansk, Poland, 80-215
    • GSK Investigational Site
  • Kraków, Poland, 31-108
    • GSK Investigational Site
  • Olsztyn, Poland, 10-228
    • GSK Investigational Site
  • Poznan, Poland, 61-866
    • GSK Investigational Site
  • Slupsk, Poland, 76-200
    • GSK Investigational Site
  • Warszawa, Poland, 02-781
    • GSK Investigational Site
  • Warszawa, Poland, 04-125
    • GSK Investigational Site
• Romania
  • Baia Mare, Romania, 430031
    • GSK Investigational Site
  • Cluj-Napoca, Romania
    • GSK Investigational Site
  • Craiova, Dolj, Romania, 200535
    • GSK Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • GSK Investigational Site
  • Kursk, Russian Federation, 305035
    • GSK Investigational Site
  • Moscow, Russian Federation, 115478
    • GSK Investigational Site
  • Omsk, Russian Federation, 644013
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 198255
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 197758
    • GSK Investigational Site
  • Stavropol, Russian Federation, 355047
    • GSK Investigational Site
• Serbia
  • Belgrad, Serbia, 11 000
    • GSK Investigational Site
  • Belgrad, Serbia
    • GSK Investigational Site
  • Sremska Kamenica, Serbia, 21204
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Pamplona, Spain, 31008
    • GSK Investigational Site
  • Sevilla, Spain, 41009
    • GSK Investigational Site
  • Valencia, Spain, 46014
    • GSK Investigational Site
• Sweden
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Malmö, Sweden, SE-205 20
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • GSK Investigational Site
  • Zürich, Switzerland, 8091
    • GSK Investigational Site
• Taiwan
  • Kaohsiung, Taiwan, 807
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taoyuan Hsien, Taiwan, 333
    • GSK Investigational Site
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • GSK Investigational Site
  • Dnipropetrovsk, Ukraine, 49100
    • GSK Investigational Site
  • Donetsk, Ukraine, 83092
    • GSK Investigational Site
  • Krivoy Rog, Ukraine, 50048
    • GSK Investigational Site
  • Kyiv, Ukraine, 03022
    • GSK Investigational Site
  • Lviv, Ukraine, 79031
    • GSK Investigational Site
• United Kingdom
  • Belfast, Northern Ireland, United Kingdom, BT9 7AB
    • GSK Investigational Site
  • Colchester, United Kingdom, CO3 3NB
    • GSK Investigational Site
  • Dundee, United Kingdom, DD1 9SY
    • GSK Investigational Site
  • London, United Kingdom, SW17 0RE
    • GSK Investigational Site
  • Poole, Dorset, United Kingdom, BH15 2JB
    • GSK Investigational Site
  • Salisbury, United Kingdom, SP2 8BJ
    • GSK Investigational Site
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • GSK Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85724-5024
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • La Jolla, California, United States, 92093-0987
      • GSK Investigational Site
    • Los Angeles, California, United States, 90025
      • GSK Investigational Site
    • Los Angeles, California, United States, 90095
      • GSK Investigational Site
    • Orange, California, United States, 92868
      • GSK Investigational Site
    • Riverside, California, United States, 92505
      • GSK Investigational Site
    • San Francisco, California, United States, 94117-1079
      • GSK Investigational Site
    • Santa Rosa, California, United States, 95403-1757
      • GSK Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • GSK Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32207
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32204
      • GSK Investigational Site
    • Miami, Florida, United States, 33136-1002
      • GSK Investigational Site
    • Orange Park, Florida, United States, 32073
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Stuart, Florida, United States, 34994
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30322
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60612-7323
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60611-2906
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • GSK Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • GSK Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21231
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
    • Boston, Massachusetts, United States, 02118
      • GSK Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48019
      • GSK Investigational Site
    • Grand Rapids, Michigan, United States, 49503
      • GSK Investigational Site
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • GSK Investigational Site
    • Minneapolis, Minnesota, United States, 55455
      • GSK Investigational Site
    • Saint Louis Park, Minnesota, United States, 55426
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • GSK Investigational Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • GSK Investigational Site
    • Morristown, New Jersey, United States, 07962-1956
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • GSK Investigational Site
    • Latham, New York, United States, 12110
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7305
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28204
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27157
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19111
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213-2584
      • GSK Investigational Site
    • Sayre, Pennsylvania, United States, 18840
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37232-6307
      • GSK Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • GSK Investigational Site
    • Austin, Texas, United States, 78759
      • GSK Investigational Site
    • Bedford, Texas, United States, 76022
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • Lubbock, Texas, United States, 79410
      • GSK Investigational Site
    • Plano, Texas, United States, 75093
      • GSK Investigational Site
    • Tyler, Texas, United States, 75702
      • GSK Investigational Site
  • Utah
    • Murray, Utah, United States, 84107
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98109
      • GSK Investigational Site
    • Vancouver, Washington, United States, 98684
      • GSK Investigational Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • GSK Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MAGE-A3 Group; Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.	Drug: GSK 2132231A; IM solution, a course of 13 injections administered over 27 months
PLACEBO_COMPARATOR: Placebo Group; Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.	Drug: Placebo; IM solution, a course of 13 injections administered over 27 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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
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
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
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
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
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
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)
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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/IFNgamma 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2008
• Primary Completion (ACTUAL): January 27, 2016
• Study Completion (ACTUAL): January 27, 2016

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (ESTIMATE): November 24, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Melanoma; Immunotherapeutic; ASCI; DERMA; Tumor antigen; Adjuvant cancer therapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 111482; 2008-002447-16 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR