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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3

Conditions: Melanoma

Treatments: Drug: Placebo; Drug: GSK 2132231A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796445

2008-002447-16 (EudraCT Number)

111482

Details and patient eligibility

About

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.

Enrollment: 1,351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,351 participants in 2 patient groups, including a placebo group

MAGE-A3 Group

Experimental group

Description:

Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Treatment:

Drug: GSK 2132231A

Placebo Group

Placebo Comparator group

Description:

Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Treatment:

Drug: Placebo