AzTrials
AzTrials

MelanomaPhase 3NCT00796445

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

A Phase 3 study testing GSK 2132231A in people with Melanoma, run by GlaxoSmithKline at 257 sites in 32 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
GSK 2132231A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,351 participants
Where
257 sitesin 32 countries
Study dates
1 Dec 2008to 27 Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

257 sites in 32 countries.

257 sites in 32 countries

United States74 sites

  • GSK Investigational Site

    Albany, New York, 12206

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Ann Arbor, Michigan, 48019

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Austin, Texas, 78759

  • GSK Investigational Site

    Baltimore, Maryland, 21231

  • GSK Investigational Site

    Baltimore, Maryland, 21237

  • GSK Investigational Site

    Bedford, Texas, 76022

  • GSK Investigational Site

    Birmingham, Alabama, 35243

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7305

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Chicago, Illinois, 60611-2906

  • GSK Investigational Site

    Chicago, Illinois, 60612-7323

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fridley, Minnesota, 55432

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Jacksonville, Florida, 32204

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    La Jolla, California, 92093-0987

  • GSK Investigational Site

    Las Vegas, Nevada, 89169

  • GSK Investigational Site

    Latham, New York, 12110

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami, Florida, 33136-1002

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    Morgantown, West Virginia, 26506

  • GSK Investigational Site

    Morristown, New Jersey, 07962-1956

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    Nashville, Tennessee, 37232-6307

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orange Park, Florida, 32073

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213-2584

  • GSK Investigational Site

    Plano, Texas, 75093

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Riverside, California, 92505

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55426

  • GSK Investigational Site

    San Francisco, California, 94117-1079

  • GSK Investigational Site

    Santa Rosa, California, 95403-1757

  • GSK Investigational Site

    Sayre, Pennsylvania, 18840

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Stuart, Florida, 34994

  • GSK Investigational Site

    Tucson, Arizona, 85724-5024

  • GSK Investigational Site

    Tyler, Texas, 75702

  • GSK Investigational Site

    Vancouver, Washington, 98684

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany37 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10249

  • GSK Investigational Site

    Berlin, 13585

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Buxtehude, Lower Saxony, 21614

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Erfurt, Thuringia, 99089

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • GSK Investigational Site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Homburg, Saarland, 66421

  • GSK Investigational Site

    Jena, Thuringia, 07740

  • GSK Investigational Site

    Kassel, Hesse, 34125

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Marburg, Hesse, 35033

  • GSK Investigational Site

    Minden, North Rhine-Westphalia, 32429

  • GSK Investigational Site

    Munich, Bavaria, 80337

  • GSK Investigational Site

    Munich, Bavaria, 80802

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Nuremberg, Bavaria, 90419

  • GSK Investigational Site

    Oldenburg, Lower Saxony, 26133

  • GSK Investigational Site

    Quedlinburg, Saxony-Anhalt, 06484

  • GSK Investigational Site

    Regensburg, Bavaria, 93053

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Wiesbaden, Hesse, 65191

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

France25 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bordeaux, 33075

  • GSK Investigational Site

    Boulogne, 92104

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Le Mans, 72000

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Limoges, 87042

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Paris, 75006

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Pierre-Bénite, 69495

  • GSK Investigational Site

    Poitiers, 86021

  • GSK Investigational Site

    Reims, 51092

  • GSK Investigational Site

    Rennes, 35042

  • GSK Investigational Site

    Rouen, 76031

  • GSK Investigational Site

    Saint-Etienne, 42055

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Italy12 sites

  • GSK Investigational Site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Meldola (FC), Emilia-Romagna, 47014

  • GSK Investigational Site

    Milan, Lombardy, 20133

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41124

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Pisa, Tuscany, 56125

  • GSK Investigational Site

    Rome, Lazio, 00144

  • GSK Investigational Site

    Siena, Tuscany, 53100

Other trials in Italy

Australia9 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Brisbane, Queensland, 4102

  • GSK Investigational Site

    Camperdown, New South Wales, 2060

  • GSK Investigational Site

    East Melbourne, Victoria, 3002

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    North Sydney, New South Wales, 2060

  • GSK Investigational Site

    Waratah, New South Wales, 2298

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Austria8 sites

  • GSK Investigational Site

    Feldkirch, A-6800

  • GSK Investigational Site

    Graz, A-8036

  • GSK Investigational Site

    Linz, A-4010

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, A-1030

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1220

  • GSK Investigational Site

    Wels, A-4600

Other trials in Austria

Poland8 sites

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Gdansk, 80-215

  • GSK Investigational Site

    Krakow, 31-108

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 61-866

  • GSK Investigational Site

    Słupsk, 76-200

  • GSK Investigational Site

    Warsaw, 02-781

  • GSK Investigational Site

    Warsaw, 04-125

Other trials in Poland

Russia7 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Omsk, 644013

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    Saint Petersburg, 198255

  • GSK Investigational Site

    Stavropol, 355047

Other trials in Russia

United Kingdom7 sites

  • GSK Investigational Site

    Belfast, Northern Ireland, BT9 7AB

  • GSK Investigational Site

    Chelmsford, Essex, CM1 7ET

  • GSK Investigational Site

    Colchester, CO3 3NB

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    London, SW17 0RE

  • GSK Investigational Site

    Poole, Dorset, BH15 2JB

  • GSK Investigational Site

    Salisbury, SP2 8BJ

Other trials in United Kingdom

Ireland6 sites

  • GSK Investigational Site

    Cork

  • GSK Investigational Site

    Dublin, 4

  • GSK Investigational Site

    Dublin, 7

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin, 9

  • GSK Investigational Site

    Galway, Co Galway

Other trials in Ireland

Ukraine6 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49100

  • GSK Investigational Site

    Dnipropetrovsk, 49102

  • GSK Investigational Site

    Donetsk, 83092

  • GSK Investigational Site

    Kryvyi Rih, 50048

  • GSK Investigational Site

    Kyiv, 03022

  • GSK Investigational Site

    Lviv, 79031

Other trials in Ukraine

Belgium5 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1180

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

Czechia5 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Ostrava, 708 52

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 128 08

Other trials in Czechia

Spain5 sites

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Seville, 41009

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

Argentina4 sites

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Cipolletti, Río Negro Province, R8324EMB

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1050AAK

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Brazil3 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30.140-001

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • GSK Investigational Site

    São Paulo, 03102-002

Other trials in Brazil

Israel3 sites

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

Other trials in Israel

New Zealand3 sites

  • GSK Investigational Site

    Auckland, 0622

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

Romania3 sites

  • GSK Investigational Site

    Baia Mare, 430031

  • GSK Investigational Site

    Cluj-Napoca

  • GSK Investigational Site

    Craiova, Dolj, 200535

Other trials in Romania

Serbia3 sites

  • GSK Investigational Site

    Belgrade, 11 000

  • GSK Investigational Site

    Belgrade

  • GSK Investigational Site

    Kamenitz, 21204

Other trials in Serbia

Sweden3 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Malmö, SE-205 20

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Taiwan3 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taoyuan Hsien, 333

Other trials in Taiwan

Bulgaria2 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Sofia, 1756

Other trials in Bulgaria

Canada2 sites

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Greece2 sites

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 185 47

Other trials in Greece

Japan2 sites

  • GSK Investigational Site

    Shizuoka, 411-8777

  • GSK Investigational Site

    Tokyo, 104-0045

Other trials in Japan

Netherlands2 sites

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Rotterdam, 3075 EA

Other trials in Netherlands

South Korea2 sites

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 06351

Other trials in South Korea

Switzerland2 sites

  • GSK Investigational Site

    Basel, 4031

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Mexico1 site

  • GSK Investigational Site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Norway1 site

  • GSK Investigational Site

    Oslo, 0310

Other trials in Norway

About this study

Official title: 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.

Conditions
Melanoma
Being tested
GSK 2132231A, Placebo
Keywords
DERMA, Tumor antigen, Immunotherapeutic, Adjuvant cancer therapy, Melanoma, ASCI
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK 2132231ADrug

    IM solution, a course of 13 injections administered over 27 months

  • PlaceboDrug

    IM solution, a course of 13 injections administered over 27 months

Study groups in NCT00796445
Study groupRoleWhat they receive
MAGE-A3 GroupExperimentalPatients 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.
Receives: Drug: GSK 2132231A
Placebo GroupPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At Final analysis (Month 30 = Year 2.5)

  2. 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).

    Measured: At follow-up analysis (up to Year 5)

Secondary outcomes (11)

  1. 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.

    Measured: At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)

  2. 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).

    Measured: At Final analysis (Month 30 = Year 2.5)

  3. 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).

    Measured: At Final analysis (Month 30 = Year 2.5)

  4. 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.

    Measured: 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

  5. 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).

    Measured: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months

  6. 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.

    Measured: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months

  7. 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.

    Measured: At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months

  8. 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.

    Measured: Within the 31-day (Days 0-30) post-treatment period

  9. 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.

    Measured: Within the 31-day (Days 0-30) follow-up period after treatment

  10. 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.

    Measured: From Day 0 up to study end (up to 5 years)

  11. 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.

    Measured: From Day 0 up to study end (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study start1 Dec 2008
  3. Primary completion27 Jan 2016
  4. Study completion27 Jan 2016

Why it stopped: The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796445
Sponsor's protocol ID
111482
Other IDs
2008-002447-16, 2008
Status last verified
Feb 2021
First submitted
21 Nov 2008
Last updated
5 Mar 2021
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

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.

    PubMed 29908991

  • 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.

    PubMed 31732522

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK 2132231A in people with Melanoma, run by GlaxoSmithKline at 257 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in United States, Germany, France, Italy, Australia and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: At Final analysis (Month 30 = Year 2.5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796445, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

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