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



Status:Terminated
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:December 1, 2008
End Date:January 27, 2016

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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.


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.
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82
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Las Vegas, Nevada 89102
1759
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Albany, New York 12206
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Amarillo, Texas 79106
1081
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Amsterdam, New York 12010
501
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Ann Arbor, Michigan 48109
165
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Atlanta, Georgia 30341
424
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Aurora, Colorado 80010
1155
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Austin, Texas 78705
1064
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Baltimore, Maryland 21201
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Bedford, Texas 76022
925
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Birmingham, Alabama 35249
493
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Boston, Massachusetts 02115
643
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Chapel Hill, North Carolina 27599
353
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Charleston, South Carolina 29425
524
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Charlotte, North Carolina 28203
348
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Charlottesville, Virginia 22903
278
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Chicago, Illinois 60611
274
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Cincinnati, Ohio 45229
96
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Ciudad Autonoma de Buenos Aires, Buenos Aires
5386
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Cleveland, Ohio 44195
129
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Dallas, Texas 75230
905
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Durham, North Carolina 27705
351
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Easley, South Carolina 29640
355
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Fort Worth, Texas 76104
937
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Fridley, Minnesota 55432
629
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Garland, Texas 75042
900
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Grand Rapids, Michigan 49546
242
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Greenville, South Carolina 29615
353
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Hackensack, New Jersey 07601
476
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Hampton, Virginia 23666
410
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Houston, Texas 77030
995
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Hudson, New York 12534
505
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Indianapolis, Indiana 46202
166
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Jacksonville, Florida 32207
672
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La Jolla, California 92093
1950
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Latham, New York 12110
517
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Little Rock, Arkansas 72205
625
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Los Angeles, California 90025
1983
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Louisville, Kentucky 40202
188
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Lubbock, Texas 79410
1131
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Maplewood, Minnesota 55109
617
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Memphis, Tennessee 38120
501
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Metairie, Louisiana 70006
795
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Miami, Florida 33136
992
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Milwaukee, Wisconsin 53215
329
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Minneapolis, Minnesota 55404
624
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Mobile, Alabama 36617
699
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Morgantown, West Virginia 26506
163
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Morristown, New Jersey 07962
453
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Murray, Utah 84107
1514
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Nashville, Tennessee 37203
333
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New York, New York 10032
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Newport News, Virginia 23606
404
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Norfolk, Virginia 23502
426
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Odessa, Texas 79761
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Orange, California 92868
1959
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Orange Park, Florida 32073
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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Plano, Texas 75093
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Portland, Oregon 97227
2026
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Rexford, New York 12148
513
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Riverside, California 92506
1929
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Rochester, Minnesota 55905
559
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Saint Louis, Missouri 63110
397
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Saint Louis Park, Minnesota 55426
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San Francisco, California 94115
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Santa Rosa, California 95403
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Sayre, Pennsylvania 18840
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Seattle, Washington 98109
2007
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Shreveport, Louisiana 71103
789
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Spartanburg, South Carolina 29303
349
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Stuart, Florida 34994
896
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Troy, New York 12180
519
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Tualatin, Oregon 97062
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Tucson, Arizona 85724
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Tyler, Texas 75702
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Vancouver, Washington 98684
2018
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Virginia Beach, Virginia 23456
439
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West Palm Beach, Florida 33409
930
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Winston-Salem, North Carolina 27103
307
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