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.
We found this trial at
82
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Sayre, Pennsylvania 18840
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Sayre, PA
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Albany, New York 12206
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Amarillo, Texas 79106
286
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Amsterdam, New York 12010
1290
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Ann Arbor, Michigan 48109
810
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Atlanta, Georgia 30341
801
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Atlanta, GA
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Aurora, Colorado 80010
403
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Austin, Texas 78705
515
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Austin, TX
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Baltimore, Maryland 21201
1148
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Bedford, Texas 76022
341
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Birmingham, Alabama 35249
676
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Boston, Massachusetts 02115
1444
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Chapel Hill, North Carolina 27599
1043
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Charleston, South Carolina 29425
1063
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Charlotte, North Carolina 28203
957
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Charlottesville, Virginia 22903
1053
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Chicago, Illinois 60611
611
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Cincinnati, Ohio 45229
727
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Ciudad Autonoma de Buenos Aires, Buenos Aires
5602
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Ciudad Autonoma de Buenos Aires,
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Cleveland, Ohio 44195
898
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Dallas, Texas 75230
340
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Durham, North Carolina 27705
1047
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Easley, South Carolina 29640
870
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Easley, SC
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Fort Worth, Texas 76104
348
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Fridley, Minnesota 55432
559
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Garland, Texas 75042
340
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Grand Rapids, Michigan 49546
737
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Greenville, South Carolina 29615
883
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Hackensack, New Jersey 07601
1285
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Hampton, Virginia 23666
1174
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Houston, Texas 77030
572
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Hudson, New York 12534
1304
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Indianapolis, Indiana 46202
643
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Indianapolis, IN
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Jacksonville, Florida 32207
1058
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La Jolla, California 92093
1142
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Las Vegas, Nevada 89102
963
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Latham, New York 12110
1309
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Little Rock, Arkansas 72205
368
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Los Angeles, California 90025
1179
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Louisville, Kentucky 40202
657
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Lubbock, Texas 79410
368
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Maplewood, Minnesota 55109
559
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Memphis, Tennessee 38120
478
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Metairie, Louisiana 70006
688
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Miami, Florida 33136
1320
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Milwaukee, Wisconsin 53215
632
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Minneapolis, Minnesota 55404
551
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Mobile, Alabama 36617
737
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Morgantown, West Virginia 26506
970
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Morristown, New Jersey 07962
1262
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Murray, Utah 84107
778
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Nashville, Tennessee 37203
618
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New York, New York 10032
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Newport News, Virginia 23606
1167
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Norfolk, Virginia 23502
1186
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Odessa, Texas 79761
482
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Orange, California 92868
1154
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Orange Park, Florida 32073
1059
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19104
1223
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Pittsburgh, Pennsylvania 15213
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Plano, Texas 75093
330
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Portland, Oregon 97227
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Rexford, New York 12148
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Riverside, California 92506
1123
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Rochester, Minnesota 55905
515
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Saint Louis, Missouri 63110
415
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Saint Louis Park, Minnesota 55426
548
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San Francisco, California 94115
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Santa Rosa, California 95403
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Seattle, Washington 98109
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Shreveport, Louisiana 71103
429
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Spartanburg, South Carolina 29303
902
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Stuart, Florida 34994
1253
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Troy, New York 12180
1313
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Tualatin, Oregon 97062
1385
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Tucson, Arizona 85724
833
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Tyler, Texas 75702
397
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Vancouver, Washington 98684
1378
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Virginia Beach, Virginia 23456
1198
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West Palm Beach, Florida 33409
1282
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Winston-Salem, North Carolina 27103
971
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