Conditions: Melanoma
Keywords: DERMA Tumor antigen Immunotherapeutic Adjuvant cancer therapy Melanoma ASCI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1351
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: GSK 2132231A intervention 2: Placebo
Intervention descriptions: intervention 1: IM solution, a course of 13 injections administered over 27 months intervention 2: IM solution, a course of 13 injections administered over 27 months

Protocol document: