Study Stopped
The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product.
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
2 other identifiers
interventional
1,351
29 countries
244
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
Longer than P75 for phase_3
244 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2016
CompletedResults Posted
Study results publicly available
March 19, 2019
CompletedMarch 5, 2021
February 1, 2021
7.2 years
November 21, 2008
September 30, 2016
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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 Outcomes (11)
Overall Survival (OS)
At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Disease-free Specific Survival (DFSS)
At Final analysis (Month 30 = Year 2.5)
Distant Metastasis-free Survival (DMFS)
At Final analysis (Month 30 = Year 2.5)
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
At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
- +6 more secondary outcomes
Study Arms (2)
MAGE-A3 Group
EXPERIMENTALPatients 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.
Placebo Group
PLACEBO 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The patient suffers from a mucosal or ocular melanoma.
- The patient has or has had any history of in-transit metastases
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (257)
GSK Investigational Site
Birmingham, Alabama, 35243, United States
GSK Investigational Site
Tucson, Arizona, 85724-5024, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
La Jolla, California, 92093-0987, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Riverside, California, 92505, United States
GSK Investigational Site
San Francisco, California, 94117-1079, United States
GSK Investigational Site
Santa Rosa, California, 95403-1757, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Miami, Florida, 33136-1002, United States
GSK Investigational Site
Orange Park, Florida, 32073, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Stuart, Florida, 34994, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Chicago, Illinois, 60611-2906, United States
GSK Investigational Site
Chicago, Illinois, 60612-7323, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Baltimore, Maryland, 21231, United States
GSK Investigational Site
Baltimore, Maryland, 21237, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Ann Arbor, Michigan, 48019, United States
GSK Investigational Site
Grand Rapids, Michigan, 49503, United States
GSK Investigational Site
Fridley, Minnesota, 55432, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Saint Louis Park, Minnesota, 55426, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Las Vegas, Nevada, 89169, United States
GSK Investigational Site
Hackensack, New Jersey, 07601, United States
GSK Investigational Site
Morristown, New Jersey, 07962-1956, United States
GSK Investigational Site
Albany, New York, 12206, United States
GSK Investigational Site
Latham, New York, 12110, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7305, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2584, United States
GSK Investigational Site
Sayre, Pennsylvania, 18840, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Memphis, Tennessee, 38104, United States
GSK Investigational Site
Nashville, Tennessee, 37232-6307, United States
GSK Investigational Site
Amarillo, Texas, 79106, United States
GSK Investigational Site
Austin, Texas, 78759, United States
GSK Investigational Site
Bedford, Texas, 76022, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Lubbock, Texas, 79410, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
Tyler, Texas, 75702, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
Charlottesville, Virginia, 22903, United States
GSK Investigational Site
Seattle, Washington, 98109, United States
GSK Investigational Site
Vancouver, Washington, 98684, United States
GSK Investigational Site
Morgantown, West Virginia, 26506, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Ciudad AutĂ³noma de Buenos Aires, Buenos Aires, C1050AAK, Argentina
GSK Investigational Site
Cipolletti, RĂo Negro Province, R8324EMB, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000KZE, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Camperdown, New South Wales, 2060, Australia
GSK Investigational Site
North Sydney, New South Wales, 2060, Australia
GSK Investigational Site
Waratah, New South Wales, 2298, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Brisbane, Queensland, 4102, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Hobart, Tasmania, 7000, Australia
GSK Investigational Site
East Melbourne, Victoria, 3002, Australia
GSK Investigational Site
Heidelberg, Victoria, 3084, Australia
GSK Investigational Site
Feldkirch, A-6800, Austria
GSK Investigational Site
Graz, A-8036, Austria
GSK Investigational Site
Linz, A-4010, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
GSK Investigational Site
Vienna, A-1030, Austria
GSK Investigational Site
Vienna, A-1090, Austria
GSK Investigational Site
Vienna, A-1220, Austria
GSK Investigational Site
Wels, A-4600, Austria
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Brussels, 1180, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30.140-001, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
GSK Investigational Site
SĂ£o Paulo, 03102-002, Brazil
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Sofia, 1756, Bulgaria
GSK Investigational Site
Winnipeg, Manitoba, R3E 0V9, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Brno, 656 53, Czechia
GSK Investigational Site
Hradec KrĂ¡lovĂ©, 500 05, Czechia
GSK Investigational Site
Ostrava, 708 52, Czechia
GSK Investigational Site
Prague, 100 34, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Bordeaux, 33075, France
GSK Investigational Site
Boulogne, 92104, France
GSK Investigational Site
Brest, 29609, France
GSK Investigational Site
Dijon, 21079, France
GSK Investigational Site
Grenoble, 38043, France
GSK Investigational Site
Le Mans, 72000, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Limoges, 87042, France
GSK Investigational Site
Marseille, 13385, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Nice, 06202, France
GSK Investigational Site
Paris, 75006, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Pierre-BĂ©nite, 69495, France
GSK Investigational Site
Poitiers, 86021, France
GSK Investigational Site
Reims, 51092, France
GSK Investigational Site
Rennes, 35042, France
GSK Investigational Site
Rouen, 76031, France
GSK Investigational Site
Saint-Etienne, 42055, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Tours, 37044, France
GSK Investigational Site
Villejuif, 94805, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
TĂ¼bingen, Baden-Wurttemberg, 72076, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89081, Germany
GSK Investigational Site
Munich, Bavaria, 80337, Germany
GSK Investigational Site
Munich, Bavaria, 80802, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90419, Germany
GSK Investigational Site
Regensburg, Bavaria, 93053, Germany
GSK Investigational Site
WĂ¼rzburg, Bavaria, 97080, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Kassel, Hesse, 34125, Germany
GSK Investigational Site
Marburg, Hesse, 35033, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65191, Germany
GSK Investigational Site
Buxtehude, Lower Saxony, 21614, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Oldenburg, Lower Saxony, 26133, Germany
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32429, Germany
GSK Investigational Site
MĂ¼nster, North Rhine-Westphalia, 48149, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Homburg, Saarland, 66421, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39120, Germany
GSK Investigational Site
Quedlinburg, Saxony-Anhalt, 06484, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105, Germany
GSK Investigational Site
LĂ¼beck, Schleswig-Holstein, 23538, Germany
GSK Investigational Site
Erfurt, Thuringia, 99089, Germany
GSK Investigational Site
Jena, Thuringia, 07740, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Berlin, 10249, Germany
GSK Investigational Site
Berlin, 13585, Germany
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 185 47, Greece
GSK Investigational Site
Cork, Ireland
GSK Investigational Site
Dublin, 4, Ireland
GSK Investigational Site
Dublin, 7, Ireland
GSK Investigational Site
Dublin, 8, Ireland
GSK Investigational Site
Dublin, 9, Ireland
GSK Investigational Site
Galway, Co Galway, Ireland
GSK Investigational Site
Haifa, 31096, Israel
GSK Investigational Site
Petah Tikva, 49100, Israel
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Bari, Apulia, 70124, Italy
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Meldola (FC), Emilia-Romagna, 47014, Italy
GSK Investigational Site
Modena, Emilia-Romagna, 41124, Italy
GSK Investigational Site
Aviano (PN), Friuli Venezia Giulia, 33081, Italy
GSK Investigational Site
Rome, Lazio, 00144, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Milan, Lombardy, 20133, Italy
GSK Investigational Site
Milan, Lombardy, 20141, Italy
GSK Investigational Site
Pisa, Tuscany, 56125, Italy
GSK Investigational Site
Siena, Tuscany, 53100, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Shizuoka, 411-8777, Japan
GSK Investigational Site
Tokyo, 104-0045, Japan
GSK Investigational Site
Monterrey, Nuevo LeĂ³n, 64710, Mexico
GSK Investigational Site
Nijmegen, 6525 GA, Netherlands
GSK Investigational Site
Rotterdam, 3075 EA, Netherlands
GSK Investigational Site
Auckland, 0622, New Zealand
GSK Investigational Site
Christchurch, 8011, New Zealand
GSK Investigational Site
Wellington, 6021, New Zealand
GSK Investigational Site
Oslo, 0310, Norway
GSK Investigational Site
Bydgoszcz, 85-796, Poland
GSK Investigational Site
Gdansk, 80-215, Poland
GSK Investigational Site
Krakow, 31-108, Poland
GSK Investigational Site
Olsztyn, 10-228, Poland
GSK Investigational Site
Poznan, 61-866, Poland
GSK Investigational Site
SÅ‚upsk, 76-200, Poland
GSK Investigational Site
Warsaw, 02-781, Poland
GSK Investigational Site
Warsaw, 04-125, Poland
GSK Investigational Site
Baia Mare, 430031, Romania
GSK Investigational Site
Cluj-Napoca, Romania
GSK Investigational Site
Craiova, Dolj, 200535, Romania
GSK Investigational Site
Chelyabinsk, 454087, Russia
GSK Investigational Site
Kursk, 305035, Russia
GSK Investigational Site
Moscow, 115478, Russia
GSK Investigational Site
Omsk, 644013, Russia
GSK Investigational Site
Saint Petersburg, 197758, Russia
GSK Investigational Site
Saint Petersburg, 198255, Russia
GSK Investigational Site
Stavropol, 355047, Russia
GSK Investigational Site
Belgrade, 11 000, Serbia
GSK Investigational Site
Belgrade, Serbia
GSK Investigational Site
Kamenitz, 21204, Serbia
GSK Investigational Site
Seoul, 05505, South Korea
GSK Investigational Site
Seoul, 06351, South Korea
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Seville, 41009, Spain
GSK Investigational Site
Valencia, 46014, Spain
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Malmo, SE-205 20, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Basel, 4031, Switzerland
GSK Investigational Site
Zurich, 8091, Switzerland
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Taoyuan Hsien, 333, Taiwan
GSK Investigational Site
Dnipropetrovsk, 49100, Ukraine
GSK Investigational Site
Dnipropetrovsk, 49102, Ukraine
GSK Investigational Site
Donetsk, 83092, Ukraine
GSK Investigational Site
Kryvyi Rih, 50048, Ukraine
GSK Investigational Site
Kyiv, 03022, Ukraine
GSK Investigational Site
Lviv, 79031, Ukraine
GSK Investigational Site
Chelmsford, Essex, CM1 7ET, United Kingdom
GSK Investigational Site
Belfast, Northern Ireland, BT9 7AB, United Kingdom
GSK Investigational Site
Colchester, CO3 3NB, United Kingdom
GSK Investigational Site
Dundee, DD1 9SY, United Kingdom
GSK Investigational Site
London, SW17 0RE, United Kingdom
GSK Investigational Site
Poole, Dorset, BH15 2JB, United Kingdom
GSK Investigational Site
Salisbury, SP2 8BJ, United Kingdom
Related Publications (2)
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.
PMID: 29908991BACKGROUNDDizier 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.
PMID: 31732522BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early on 08 Sep 2015 following assessment of the two co-primary endpoints showed the lack of efficacy of the study product.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
December 1, 2008
Primary Completion
January 27, 2016
Study Completion
January 27, 2016
Last Updated
March 5, 2021
Results First Posted
March 19, 2019
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- 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 is available via the Clinical Study Data Request site (click on the link provided below)