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
NCT ID: NCT00796445
Last Updated: 2021-03-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1351 participants
INTERVENTIONAL
2008-12-01
2016-01-27
Brief Summary
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This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
GSK 2132231A
IM solution, a course of 13 injections administered over 27 months
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.
Placebo
IM solution, a course of 13 injections administered over 27 months
Interventions
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GSK 2132231A
IM solution, a course of 13 injections administered over 27 months
Placebo
IM solution, a course of 13 injections administered over 27 months
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Riverside, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Stuart, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Grand Rapids, Michigan, United States
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Fridley, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Albany, New York, United States
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Latham, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Plano, Texas, United States
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Tyler, Texas, United States
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Murray, Utah, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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Vancouver, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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Cipolletti, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Camperdown, New South Wales, Australia
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North Sydney, New South Wales, Australia
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Waratah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Hobart, Tasmania, Australia
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East Melbourne, Victoria, Australia
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Heidelberg, Victoria, Australia
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Feldkirch, , Austria
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Wels, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Wilrijk, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Winnipeg, Manitoba, Canada
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Ottawa, Ontario, Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Besançon, , France
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Bordeaux, , France
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Boulogne, , France
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Brest, , France
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Dijon, , France
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Grenoble, , France
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Le Mans, , France
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Lille, , France
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Limoges, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Reims, , France
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Rennes, , France
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Rouen, , France
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Saint-Etienne, , France
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Toulouse, , France
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Tours, , France
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Villejuif, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Heidelberg, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Kassel, Hesse, Germany
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Marburg, Hesse, Germany
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Wiesbaden, Hesse, Germany
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Buxtehude, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Oldenburg, Lower Saxony, Germany
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Greifswald, Mecklenburg-Vorpommern, Germany
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Bonn, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Minden, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
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Mainz, Rhineland-Palatinate, Germany
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Homburg, Saarland, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Quedlinburg, Saxony-Anhalt, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Erfurt, Thuringia, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Athens, , Greece
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Athens, , Greece
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Bari, Apulia, Italy
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Napoli, Campania, Italy
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Meldola (FC), Emilia-Romagna, Italy
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Modena, Emilia-Romagna, Italy
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Aviano (PN), Friuli Venezia Giulia, Italy
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Rome, Lazio, Italy
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Genoa, Liguria, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Pisa, Tuscany, Italy
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Siena, Tuscany, Italy
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Padua, Veneto, Italy
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Shizuoka, , Japan
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Tokyo, , Japan
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Monterrey, Nuevo León, Mexico
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Oslo, , Norway
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Craiova, Dolj, , Romania
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Chelyabinsk, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Taoyuan Hsien, , Taiwan
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kryvyi Rih, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Chelmsford, Essex, United Kingdom
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Belfast, Northern Ireland, , United Kingdom
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Colchester, , United Kingdom
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Dundee, , United Kingdom
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London, , United Kingdom
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Poole, Dorset, , United Kingdom
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Salisbury, , United Kingdom
Countries
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References
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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.
Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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2008-002447-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
111482
Identifier Type: -
Identifier Source: org_study_id
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