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

Use our guide to learn which trials are right for you!

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
sites
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Amsterdam, New York 12010
?
mi
from
Amsterdam, NY
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires
?
mi
from
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Easley, South Carolina 29640
?
mi
from
Easley, SC
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Garland, Texas 75042
?
mi
from
Garland, TX
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Hampton, Virginia 23666
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hudson, New York 12534
?
mi
from
Hudson, NY
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Latham, New York 12110
?
mi
from
Latham, NY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lubbock, Texas 79410
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Maplewood, Minnesota 55109
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
Memphis, Tennessee 38120
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mobile, Alabama 36617
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Morgantown, West Virginia 26506
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23606
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Odessa, Texas 79761
?
mi
from
Odessa, TX
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75093
?
mi
from
Plano, TX
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rexford, New York 12148
?
mi
from
Rexford, NY
Click here to add this to my saved trials
Riverside, California 92506
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis Park, Minnesota 55426
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Sayre, Pennsylvania 18840
?
mi
from
Sayre, PA
Click here to add this to my saved trials
Seattle, Washington 98109
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Stuart, Florida 34994
?
mi
from
Stuart, FL
Click here to add this to my saved trials
Troy, New York 12180
?
mi
from
Troy, NY
Click here to add this to my saved trials
Tualatin, Oregon 97062
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tyler, Texas 75702
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Vancouver, Washington 98684
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Virginia Beach, Virginia 23456
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
West Palm Beach, Florida 33409
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials