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
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|ClinicalTrials.gov Identifier: NCT00796445|
Recruitment Status : Terminated (The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product.)
First Posted : November 24, 2008
Last Update Posted : September 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: GSK 2132231A Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1351 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma|
|Study Start Date :||December 2008|
|Primary Completion Date :||September 2015|
|Study Completion Date :||January 2016|
Experimental: MAGE-A3 Group
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI.
Drug: GSK 2132231A
IM solution, a course of 13 injections will be administered over 27 months
Placebo Comparator: Placebo Group
Patients who received up to 13 doses of placebo.
IM solution, a course of 13 injections will be administered over 27 months
- Disease Free Survival (DFS) [ Time Frame: At Final analysis (23 May 2013) and at follow-up analysis (18 Aug 2015) ]
DFS was defined as the time from randomization to either the date of first recurrence of the disease (date as assessed by the investigator) or the date of death (whatever the cause), whichever occurred first.
Notes: -Types of recurrence to be considered as an event included loco-regional and distant metastases. -In addition, any death occurring without prior documentation of tumor recurrence was considered as an event (and was not censored in the statistical analysis) as this approach was less prone to introduce bias. -If no event occurred by the time of the analysis, then the time to event was censored at the date of the last assessment (tumor assessment/visit) of the patient in question. -Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
- Overall Survival (OS) [ Time Frame: At final analysis (23 May 2013) and Follow-up analysis (18 Aug 2015) ]Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death; Patients alive at the time of the analysis were censored on the date last known to be alive.
- Disease-free specific survival (DFSS) [ Time Frame: At Final analysis (23 May 2013) ]Disease Free Specific Survival (DFSS) was defined as the interval from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
- Distant metastasis-free survival (DMFS) [ Time Frame: At Final analysis (23 May 2013) ]Distant Metastasis Free Survival (DMFS) was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
- Health-related quality of life [ Time Frame: At various protocol-defined timepoints: Week 0, 6, 12, on and the day after the day of treatment administration (TA), at Month 6, 9, 12, 24, at the Concluding visit + 6 months and +12 Months and at disease recurrence ]The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the EQ-5D questionnaire was available in their native language.
- Number of subjects with Anti-MAGE-A3 antibody concentrations above the cut-off values [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ]The cut-off value was 27 ELISA units per millilitre (EL.U/mL).
- Anti-MAGE-A3 antibody geometric mean concentration [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ]Geometric mean concentration (GMC) was expressed as ELISA units per millilitre (EL.U/mL).
- Number of subjects with Anti-MAGE-A3 antibody response [ Time Frame: After 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2) ]
Treatment response defined as:
- For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EL.U/mL;
- For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
- Number of subjects with any adverse events (AEs) [ Time Frame: Up to 30 days after each study dose ]An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
- Number of subjects with any serious adverse events (SAEs) [ Time Frame: Up to 30 days after the last administration of study treatment ]Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
- Number of subjects with potential immune-mediated diseases (pIMDs) [ Time Frame: Up to 30 days after the last administration of study treatment ]Mediated Disorders (pIMDs) were to be collected up to 5 years after first treatment administration or study withdrawal.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796445
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|