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
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Seattle, Washington 98109
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Albany, New York 12206
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Amarillo, Texas 79106
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Amsterdam, New York 12010
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30341
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Aurora, Colorado 80010
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Austin, Texas 78705
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Baltimore, Maryland 21201
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Bedford, Texas 76022
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Birmingham, Alabama 35249
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Boston, Massachusetts 02115
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Chapel Hill, North Carolina 27599
2194
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28203
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Charlottesville, Virginia 22903
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Chicago, Illinois 60611
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Cincinnati, Ohio 45229
1880
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Cleveland, Ohio 44195
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Dallas, Texas 75230
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Durham, North Carolina 27705
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Easley, South Carolina 29640
2007
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Fort Worth, Texas 76104
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Fridley, Minnesota 55432
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Garland, Texas 75042
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Grand Rapids, Michigan 49546
1845
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Greenville, South Carolina 29615
2022
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Hackensack, New Jersey 07601
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Hampton, Virginia 23666
2329
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Houston, Texas 77030
1357
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Hudson, New York 12534
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32207
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La Jolla, California 92093
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Latham, New York 12110
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Lubbock, Texas 79410
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Maplewood, Minnesota 55109
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Memphis, Tennessee 38120
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Metairie, Louisiana 70006
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Miami, Florida 33136
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Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55404
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Mobile, Alabama 36617
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Morgantown, West Virginia 26506
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Morristown, New Jersey 07962
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Murray, Utah 84107
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Nashville, Tennessee 37203
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New York, New York 10032
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Newport News, Virginia 23606
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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
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Rexford, New York 12148
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Riverside, California 92506
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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Saint Louis Park, Minnesota 55426
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Santa Rosa, California 95403
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Sayre, Pennsylvania 18840
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Shreveport, Louisiana 71103
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Spartanburg, South Carolina 29303
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Stuart, Florida 34994
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Troy, New York 12180
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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
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Virginia Beach, Virginia 23456
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Winston-Salem, North Carolina 27103
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