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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00796445
First received: November 21, 2008
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: GSK 2132231A
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: Once the pre-defined number of events is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Disease-free specific survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Anti-MAGE-A3 and anti-protein D seropositivity status. [ Time Frame: Post-treatment and 1 year after concluding visit. ] [ Designated as safety issue: No ]
  • Occurrence of adverse events including abnormal haematological and biochemical parameters. [ Time Frame: Up to 30 days after each study dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events and autoimmunity events. [ Time Frame: During the whole study duration up to 30 days after the last administration of study treatment. ] [ Designated as safety issue: No ]
  • Health-related quality of life (utility) assessment using the EuroQoL 5D (EQ-5D) questionnaire. [ Time Frame: At regular intervals from Visit 1 (baseline) till 6 months after the concluding visit or 1 year post-recurrence. ] [ Designated as safety issue: No ]

Enrollment: 1351
Study Start Date: December 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Drug: GSK 2132231A
IM solution, a course of 13 injections will be administered over 27 months
Placebo Comparator: Group B
Not Applicable
Drug: Placebo
IM solution, a course of 13 injections will be administered over 27 months

Detailed Description:

"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic approach in an easy-to-understand format" "http://www.ascitrials.com gives practical information on the MAGRIT clinical study"

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796445

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Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35243
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
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Tucson, Arizona, United States, 85724-5024
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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La Jolla, California, United States, 92093-0987
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Los Angeles, California, United States, 90025
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Los Angeles, California, United States, 90095
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Orange, California, United States, 92868
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Riverside, California, United States, 92505
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San Francisco, California, United States, 94117-1079
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Santa Rosa, California, United States, 95403-1757
United States, Colorado
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Aurora, Colorado, United States, 80045
United States, Florida
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Jacksonville, Florida, United States, 32204
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Jacksonville, Florida, United States, 32207
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Miami, Florida, United States, 33136-1002
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Orange Park, Florida, United States, 32073
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Orlando, Florida, United States, 32806
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Stuart, Florida, United States, 34994
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30309
United States, Illinois
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612-7323
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Chicago, Illinois, United States, 60611-2906
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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Metairie, Louisiana, United States, 70006
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Shreveport, Louisiana, United States, 71101
United States, Maryland
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Baltimore, Maryland, United States, 21231
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Baltimore, Maryland, United States, 21237
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
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Boston, Massachusetts, United States, 02118
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Boston, Massachusetts, United States, 02215
United States, Michigan
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Ann Arbor, Michigan, United States, 48019
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Grand Rapids, Michigan, United States, 49503
United States, Minnesota
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Fridley, Minnesota, United States, 55432
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Maplewood, Minnesota, United States, 55109
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Minneapolis, Minnesota, United States, 55455
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Minneapolis, Minnesota, United States, 55404
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Rochester, Minnesota, United States, 55905
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St. Louis Park, Minnesota, United States, 55426
United States, Missouri
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St. Louis, Missouri, United States, 63110
United States, Nevada
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Las Vegas, Nevada, United States, 89169
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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Morristown, New Jersey, United States, 07962-1956
United States, New York
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Albany, New York, United States, 12208
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Albany, New York, United States, 12206
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Amsterdam, New York, United States, 12010
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Hudson, New York, United States, 12534
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Latham, New York, United States, 12110
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New York, New York, United States, 10016
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Rexford, New York, United States, 12148
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Troy, New York, United States, 12180
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599-7305
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Charlotte, North Carolina, United States, 28204
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Durham, North Carolina, United States, 27710
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Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44106
United States, Oregon
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Portland, Oregon, United States, 97227
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Portland, Oregon, United States, 97213
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Portland, Oregon, United States, 97225
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Tualatin, Oregon, United States, 97062
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15213-2584
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Sayre, Pennsylvania, United States, 18840
United States, South Carolina
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Charleston, South Carolina, United States, 29406
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Charleston, South Carolina, United States, 29403
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Charleston, South Carolina, United States, 29425
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Easley, South Carolina, United States, 29640
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Greenville, South Carolina, United States, 29615
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Greenville, South Carolina, United States, 29605
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Spartanburg, South Carolina, United States, 29307
United States, Tennessee
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Memphis, Tennessee, United States, 38104
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Nashville, Tennessee, United States, 37232-6307
United States, Texas
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Amarillo, Texas, United States, 79106
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Austin, Texas, United States, 78759
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Bedford, Texas, United States, 76022
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75246
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Fort Worth, Texas, United States, 76104
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Fort Worth, Texas, United States, 76132
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Garland, Texas, United States, 75042
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Houston, Texas, United States, 77030
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Lubbock, Texas, United States, 79410
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Odessa, Texas, United States, 79761
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Plano, Texas, United States, 75093
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Tyler, Texas, United States, 75702
United States, Utah
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Murray, Utah, United States, 84107
United States, Virginia
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Charlottesville, Virginia, United States, 22903
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Hampton, Virginia, United States, 23666
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Newport News, Virginia, United States, 23606
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Norfolk, Virginia, United States, 23502
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Virginia Beach, Virginia, United States, 23456
United States, Washington
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Seattle, Washington, United States, 98109
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Vancouver, Washington, United States, 98684
United States, West Virginia
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Morgantown, West Virginia, United States, 26506
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53215
Argentina
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Caba, Buenos Aires, Argentina, C1425DTG
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1050AAK
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Cipolletti, Río Negro, Argentina, R8324EMB
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Rosario, Santa Fe, Argentina, S2000KZE
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2060
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Newcastle, New South Wales, Australia, 2300
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North Sydney, New South Wales, Australia, 2060
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Westmead, New South Wales, Australia, 2145
Australia, Queensland
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Brisbane, Queensland, Australia, 4102
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
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Heidelberg, Victoria, Australia, 3084
Austria
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Feldkirch, Austria, A-6800
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Graz, Austria, A-8036
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Linz, Austria, A-4010
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Salzburg, Austria, A-5020
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Wels, Austria, A-4600
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Wien, Austria, A-1220
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Wien, Austria, A-1130
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Wien, Austria, A-1030
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Wien, Austria, A-1090
Belgium
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Bruxelles, Belgium, 1070
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Bruxelles, Belgium, 1180
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Bruxelles, Belgium, 1200
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Liège, Belgium, 4000
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Roeselare, Belgium, 8800
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Wilrijk, Belgium, 2610
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30150-270
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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São Paulo, Brazil, 01308-050
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São Paulo, Brazil, 03102-002
Bulgaria
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Plovdiv, Bulgaria, 4000
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Sofia, Bulgaria, 1756
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
Czech Republic
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Brno, Czech Republic, 656 53
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Hradec Kralove, Czech Republic, 500 05
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Ostrava, Czech Republic, 708 52
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Praha 10, Czech Republic, 100 34
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Praha 2, Czech Republic, 128 08
Estonia
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Tallinn, Estonia, 13419
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Tartu, Estonia, 51014
France
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Besançon cedex, France, 25030
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Bordeaux, France, 33075
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Boulogne, France, 92104
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Brest, France, 29609
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Dijon, France, 21079
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Grenoble, France, 38043
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Le Mans, France, 72000
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Lille, France, 59037
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Limoges cedex, France, 87042
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Marseille Cedex 5, France, 13385
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Montpellier, France, 34295
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Nantes, France, 44093
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Nice, France, 06202
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Paris, France, 75018
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Paris, France, 75006
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Paris Cedex 10, France, 75475
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Pierre-Bénite cedex, France, 69495
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Poitiers, France, 86021
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Reims, France, 51092
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Rennes, France, 35042
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Rouen, France, 76031
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Saint-Etienne, France, 42055
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Toulouse cedex 9, France, 31059
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Tours, France, 37044
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Villejuif, France, 94805
Germany
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Freiburg, Baden-Wuerttemberg, Germany, 79104
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Heidelberg, Baden-Wuerttemberg, Germany, 69120
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Mannheim, Baden-Wuerttemberg, Germany, 68167
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
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Ulm, Baden-Wuerttemberg, Germany, 89081
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Muenchen, Bayern, Germany, 80802
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Muenchen, Bayern, Germany, 80337
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Nuernberg, Bayern, Germany, 90419
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Regensburg, Bayern, Germany, 93053
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Wuerzburg, Bayern, Germany, 97080
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Frankfurt, Hessen, Germany, 60590
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Kassel, Hessen, Germany, 34125
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Marburg, Hessen, Germany, 35033
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Wiesbaden, Hessen, Germany, 65191
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Greifswald, Mecklenburg-Vorpommern, Germany, 17475
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Schwerin, Mecklenburg-Vorpommern, Germany, 19049
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Buxtehude, Niedersachsen, Germany, 21614
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Hannover, Niedersachsen, Germany, 30625
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Oldenburg, Niedersachsen, Germany, 26133
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Bochum, Nordrhein-Westfalen, Germany, 44791
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Bonn, Nordrhein-Westfalen, Germany, 53127
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Duesseldorf, Nordrhein-Westfalen, Germany, 40225
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Essen, Nordrhein-Westfalen, Germany, 45122
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Koeln, Nordrhein-Westfalen, Germany, 50937
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Minden, Nordrhein-Westfalen, Germany, 32429
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Muenster, Nordrhein-Westfalen, Germany, 48149
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Ludwigshafen, Rheinland-Pfalz, Germany, 67063
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Mainz, Rheinland-Pfalz, Germany, 55131
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Homburg, Saarland, Germany, 66421
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Magdeburg, Sachsen-Anhalt, Germany, 39120
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Quedlinburg, Sachsen-Anhalt, Germany, 06484
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Dresden, Sachsen, Germany, 01307
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Leipzig, Sachsen, Germany, 04103
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Kiel, Schleswig-Holstein, Germany, 24105
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Luebeck, Schleswig-Holstein, Germany, 23538
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Erfurt, Thueringen, Germany, 99089
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Jena, Thueringen, Germany, 07740
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Berlin, Germany, 10249
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Berlin, Germany, 13585
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Berlin, Germany, 10117
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Berlin, Germany, 12351
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Hamburg, Germany, 20099
Greece
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Athens, Greece, 185 47
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Athens, Greece, 11527
Ireland
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Cork, Ireland
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Dublin, Ireland, 7
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Dublin, Ireland, 8
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Dublin, Ireland, 9
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Dublin, Ireland, 4
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Galway, Ireland, Co Galway
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Waterford, Ireland
Israel
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Haifa, Israel, 31096
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
Italy
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Napoli, Campania, Italy, 80131
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Meldola (FC), Emilia-Romagna, Italy, 47014
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Modena, Emilia-Romagna, Italy, 41124
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Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
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Roma, Lazio, Italy, 00167
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Roma, Lazio, Italy, 00144
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Genova, Liguria, Italy, 16132
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Milano, Lombardia, Italy, 20133
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Milano, Lombardia, Italy, 20141
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Bari, Puglia, Italy, 70124
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Cagliari, Sardegna, Italy, 09100
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Pisa, Toscana, Italy, 56125
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Siena, Toscana, Italy, 53100
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Perugia, Umbria, Italy, 06132
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Padova, Veneto, Italy, 35128
Japan
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Shizuoka, Japan, 411-8777
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Tokyo, Japan, 104-0045
Korea, Republic of
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Kyunggi do, Korea, Republic of, 410-769
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 135-710
Mexico
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Monterrey, Nuevo León, Mexico, 64710
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Aguascalientes, Mexico, 20127
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Mexico City, Mexico, CP 14080
Netherlands
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3075 EA
New Zealand
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Auckland, New Zealand, 0622
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Christchurch, New Zealand, 8011
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Wellington, New Zealand, 6021
Norway
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Oslo, Norway, 0310
Poland
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Bydgoszcz, Poland, 85-796
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Gdansk, Poland, 80-215
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Kraków, Poland, 31-108
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Olsztyn, Poland, 10-228
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Poznan, Poland, 61-866
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Slupsk, Poland, 76-200
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Warszawa, Poland, 02-781
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Warszawa, Poland, 04-125
Romania
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Baia Mare, Romania, 43031
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Bucuresti, Romania, 022328
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Cluj-Napoca, Romania
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Craiova, Dolj, Romania, 200535
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 115478
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Omsk, Russian Federation, 644013
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Pyatigorsk, Russian Federation, 357502
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St. Petersburg, Russian Federation, 198255
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St. Petersburg, Russian Federation, 197758
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Stavropol, Russian Federation, 355047
Serbia
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Belgrad, Serbia
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Belgrad, Serbia, 11 000
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Sremska Kamenica, Serbia, 21204
Spain
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Barcelona, Spain, 08036
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Madrid, Spain, 28040
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Pamplona, Spain, 31008
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Sevilla, Spain, 41009
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Valencia, Spain, 46014
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Zaragoza, Spain, 50009
Sweden
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Göteborg, Sweden, SE-413 45
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Malmö, Sweden, SE-205 20
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Uppsala, Sweden, SE-751 85
Switzerland
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Basel, Switzerland, 4031
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Lausanne, Switzerland, 1011
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St Gallen, Switzerland
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Zürich, Switzerland, 8091
Taiwan
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Kaohsiung, Taiwan, 807
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Taipei, Taiwan, 112
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Taoyuan Hsien, Taiwan, 333
Ukraine
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Dnipropetrovsk, Ukraine, 49100
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Dnipropetrovsk, Ukraine, 49102
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Donetsk, Ukraine, 83092
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Kryvyi Rih, Ukraine, 50048
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Kyiv, Ukraine, 03022
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Lviv, Ukraine, 79031
United Kingdom
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Chelmsford, Essex, United Kingdom, CM1 7ET
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Belfast, Northern Ireland, United Kingdom, BT9 7AB
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Colchester, United Kingdom, CO3 3NB
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Dorchester, United Kingdom, DT1 2JY
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Dundee, United Kingdom, DD1 9SY
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London, United Kingdom, SW17 0RE
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Poole, Dorset, United Kingdom, BH15 2JB
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Salisbury, United Kingdom, SP2 8BJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00796445     History of Changes
Other Study ID Numbers: 111482
Study First Received: November 21, 2008
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
DERMA
Melanoma
Immunotherapeutic
Adjuvant cancer therapy
ASCI
Tumor antigen

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014