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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
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: GSK 2132231A
Drug: Placebo
Enrollment 1351
Recruitment Details  
Pre-assignment Details Some of the enrolled patients did not receive treatment and were excluded from study start (Total Treated population: 1345). Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the TT population-as treated, which included 1344 patients: 894 in the MAGE-A3 Group and 450 in the Placebo Group.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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. 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.
Period Title: Overall Study
Started [1] 894 450
Completed 310 158
Not Completed 584 292
Reason Not Completed
Protocol Violation             5             3
Adverse event, serious fatal             10             5
Adverse event, non-fatal             4             0
Disease progression/recurrence             537             268
Other             10             7
Withdrawal by Subject             18             9
[1]
1 patient from the MAGE-A3 Group had an invalid ICF and was not included in the follow-up analysis.
Arm/Group Title MAGE-A3 Group Placebo Group Total
Hide Arm/Group Description Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCIStudy 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 895 450 1345
Hide Baseline Analysis Population Description
Demography data was collected before the follow-up analysis stage, when the Total Treated population-as treated included 1345 subjects, because it was not yet found that 1 patient had an invalid Informed Consent Form.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 895 participants 450 participants 1345 participants
56.0  (13.51) 56.2  (13.66) 56.1  (13.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 895 participants 450 participants 1345 participants
Female
345
  38.5%
188
  41.8%
533
  39.6%
Male
550
  61.5%
262
  58.2%
812
  60.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 895 participants 450 participants 1345 participants
Asian - Japanese Heritage
4
   0.4%
3
   0.7%
7
   0.5%
White - Arabic/North African Heritage
4
   0.4%
1
   0.2%
5
   0.4%
White - Caucasian/European Heritage
880
  98.3%
443
  98.4%
1323
  98.4%
Other - Mixed origin
7
   0.8%
3
   0.7%
10
   0.7%
1.Primary Outcome
Title Disease Free Survival (DFS)
Hide Description DFS = time from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. 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).
Time Frame At Final analysis (Month 30 = Year 2.5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Arm/Group Title MAGE-A3 Group Placebo Group GS+ Mage-A3 Sub-Group GS+ Placebo Sub-Group GS- Mage-A3 Sub-Group GS- Placebo Sub-Group
Hide Arm/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.
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.
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Overall Number of Participants Analyzed 893 452 200 116 255 126
Measure Type: Number
Unit of Measure: Years
1133.75 593.63 376.57 226.58 519.12 247.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAGE-A3 Group, Placebo Group
Comments At Final analysis (Month 30)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.
Statistical Test of Hypothesis P-Value 0.8566
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.013
Confidence Interval (2-Sided) 95%
0.879 to 1.169
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GS+ Mage-A3 Sub-Group, GS+ Placebo Sub-Group
Comments At Final analysis (Month 30)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.
Statistical Test of Hypothesis P-Value 0.4821
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.111
Confidence Interval (2-Sided) 95%
0.828 to 1.491
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GS- Mage-A3 Sub-Group, GS- Placebo Sub-Group
Comments At Final analysis (Month 30)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature
Statistical Test of Hypothesis P-Value 0.5375
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.915
Confidence Interval (2-Sided) 95%
0.691 to 1.212
Estimation Comments [Not Specified]
2.Primary Outcome
Title Disease Free Survival (DFS)
Hide Description DFS = time from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. 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).
Time Frame At follow-up analysis (up to Year 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.
Arm/Group Title MAGE-A3 Group Placebo Group GS+ Mage-A3 Sub-Group GS+ Placebo Sub-Group GS- Mage-A3 Sub-Group GS- Placebo Sub-Group
Hide Arm/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.
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.
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Overall Number of Participants Analyzed 892 452 200 116 255 126
Measure Type: Number
Unit of Measure: Years
1652.18 860.92 376.57 226.58 519.12 247.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAGE-A3 Group, Placebo Group
Comments At Follow-up analysis (up to Year 5)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement
Statistical Test of Hypothesis P-Value 0.7534
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.023
Confidence Interval (2-Sided) 95%
0.890 to 1.175
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GS+ Mage-A3 Sub-Group, GS+ Placebo Sub-Group
Comments At Follow-up analysis (up to Year 5)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.
Statistical Test of Hypothesis P-Value 0.5385
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.094
Confidence Interval (2-Sided) 95%
0.821 to 1.457
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GS- Mage-A3 Sub-Group, GS- Placebo Sub-Group
Comments At Follow-up analysis (up to Year 5)
Type of Statistical Test Non-Inferiority
Comments The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.
Statistical Test of Hypothesis P-Value 0.5419
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.918
Confidence Interval (2-Sided) 95%
0.698 to 1.207
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. OS was expressed as the sum of follow-up periods, in years, until the occurrence of death.
Time Frame At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.
Arm/Group Title MAGE-A3 Group Placebo Group GS+ Mage-A3 Sub-Group GS+ Placebo Sub-Group GS- Mage-A3 Sub-Group GS- Placebo Sub-Group
Hide Arm/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.
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.
Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Overall Number of Participants Analyzed 893 452 200 116 255 126
Measure Type: Number
Unit of Measure: Years
OS, Final analysis Number Analyzed 893 participants 452 participants 200 participants 116 participants 255 participants 126 participants
1778.69 926.72 389.04 234.33 534.05 265.51
OS, Follow-up analysis Number Analyzed 892 participants 452 participants 200 participants 116 participants 255 participants 126 participants
2751.06 1407.60 609.11 352.50 819.82 406.90
4.Secondary Outcome
Title Disease-free Specific Survival (DFSS)
Hide Description 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. DFSS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. 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).
Time Frame At Final analysis (Month 30 = Year 2.5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Arm/Group Title MAGE-A3 Group Placebo Group GS+ Mage-A3 Sub-Group GS- Mage-A3 Sub-Group GS+ Placebo Sub-Group GS- Placebo Sub-Group
Hide Arm/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.
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.
Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Overall Number of Participants Analyzed 893 452 200 116 255 126
Measure Type: Number
Unit of Measure: Years
1133.75 593.63 248.04 156.50 352.73 169.83
5.Secondary Outcome
Title Distant Metastasis-free Survival (DMFS)
Hide Description 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. DMFS was expressed as the sum of follow-up periods, in years, until the first occurrence of distant metastasis/death. 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).
Time Frame At Final analysis (Month 30 = Year 2.5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Arm/Group Title MAGE-A3 Group Placebo Group GS+ Mage-A3 Sub-Group GS+ Placebo Sub-Group GS- Mage-A3 Sub-Group GS- Placebo Sub-Group
Hide Arm/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.
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.
Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. 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.
Overall Number of Participants Analyzed 893 452 200 116 255 126
Measure Type: Number
Unit of Measure: Years
1295.76 704.91 281.05 181.27 403.77 204.88
6.Secondary Outcome
Title Health-related Quality of Life
Hide Description 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 Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.
Time Frame At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with valid EQ-5D data from the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 245 118
Mean (Standard Deviation)
Unit of Measure: Units on a scale
EQ-5D, Week 0 (day of TA) Number Analyzed 245 participants 118 participants
0.842  (0.182) 0.861  (0.159)
EQ-5D, Week 0 (day after TA) Number Analyzed 195 participants 94 participants
0.773  (0.182) 0.873  (0.141)
EQ-5D, Week 6 (day of TA) Number Analyzed 234 participants 118 participants
0.853  (0.183) 0.865  (0.173)
EQ-5D, Week 6 (day after TA) Number Analyzed 198 participants 96 participants
0.722  (0.245) 0.867  (0.174)
EQ-5D, Week 12 (day of TA) Number Analyzed 193 participants 96 participants
0.873  (0.158) 0.887  (0.138)
EQ-5D, Week 12 (day after TA) Number Analyzed 162 participants 77 participants
0.788  (0.170) 0.888  (0.126)
EQ-5D, Month 6 Number Analyzed 144 participants 75 participants
0.879  (0.146) 0.900  (0.156)
EQ-5D, Month 9 Number Analyzed 130 participants 77 participants
0.891  (0.134) 0.876  (0.194)
EQ-5D, Month 12 Number Analyzed 113 participants 67 participants
0.891  (0.157) 0.899  (0.149)
EQ-5D, Month 24 Number Analyzed 62 participants 36 participants
0.894  (0.132) 0.881  (0.150)
EQ-5D, Month 30 + 6 months Number Analyzed 1 participants 2 participants
0.727  (0.000) 0.568  (0.074)
EQ-5D, Month 30 + 12 months Number Analyzed 30 participants 10 participants
0.791  (0.264) 0.648  (0.344)
EQ-5D, Disease recurrence Number Analyzed 76 participants 35 participants
0.752  (0.261) 0.815  (0.197)
7.Secondary Outcome
Title Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Hide Description The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time Frame At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 629 316
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-MAGE-A3, Week 0 Number Analyzed 629 participants 316 participants
25
   4.0%
19
   6.0%
Anti-MAGE-A3, Week 6 Number Analyzed 482 participants 271 participants
478
  99.2%
22
   8.1%
Anti-MAGE-A3, Week 12 Number Analyzed 425 participants 230 participants
424
  99.8%
13
   5.7%
Anti-MAGE-A3, Week 36 Number Analyzed 259 participants 131 participants
259
 100.0%
6
   4.6%
Anti-MAGE-A3, Week 48 Number Analyzed 224 participants 113 participants
224
 100.0%
5
   4.4%
Anti-MAGE-A3, Week 72 Number Analyzed 178 participants 85 participants
178
 100.0%
4
   4.7%
Anti-MAGE-A3, Week 120 Number Analyzed 257 participants 140 participants
257
 100.0%
10
   7.1%
Anti-MAGE-A3, Week 120+6 months Number Analyzed 70 participants 36 participants
70
 100.0%
1
   2.8%
8.Secondary Outcome
Title Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Hide Description Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.
Time Frame At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 629 316
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-MAGE-A3, Week 0 Number Analyzed 629 participants 316 participants
11.0
(10.6 to 11.4)
11.4
(10.7 to 12.1)
Anti-MAGE-A3, Week 6 Number Analyzed 482 participants 271 participants
1451.6
(1290.9 to 1632.3)
11.9
(11.0 to 12.9)
Anti-MAGE-A3, Week 12 Number Analyzed 425 participants 230 participants
4031.6
(3738.7 to 4347.4)
11.3
(10.6 to 12.1)
Anti-MAGE-A3, Week 36 Number Analyzed 259 participants 131 participants
2189.6
(2000.4 to 2396.7)
11.4
(10.4 to 12.4)
Anti-MAGE-A3, Week 48 Number Analyzed 224 participants 113 participants
2243.4
(2034.4 to 2473.8)
11.3
(10.2 to 12.6)
Anti-MAGE-A3, Week 72 Number Analyzed 178 participants 85 participants
2489.4
(2221.8 to 2789.4)
11.2
(10.0 to 12.5)
Anti-MAGE-A3, Week 120 Number Analyzed 257 participants 140 participants
3109.7
(2827.4 to 3420.2)
12.7
(10.9 to 14.8)
Anti-MAGE-A3, Week 120+6 months Number Analyzed 70 participants 36 participants
1293.4
(1056.3 to 1583.7)
10.8
(9.9 to 11.8)
9.Secondary Outcome
Title Number of Subjects With Anti-MAGE-A3 Antibody Response
Hide Description 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.
Time Frame At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 482 271
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-MAGE-A3, Week 6 Number Analyzed 482 participants 271 participants
476
  98.8%
9
   3.3%
Anti-MAGE-A3, Week 12 Number Analyzed 425 participants 230 participants
424
  99.8%
4
   1.7%
Anti-MAGE-A3, Week 36 Number Analyzed 259 participants 131 participants
259
 100.0%
2
   1.5%
Anti-MAGE-A3, Week 48 Number Analyzed 224 participants 113 participants
224
 100.0%
2
   1.8%
Anti-MAGE-A3, Week 72 Number Analyzed 178 participants 85 participants
178
 100.0%
2
   2.4%
Anti-MAGE-A3, Week 120 Number Analyzed 257 participants 140 participants
257
 100.0%
6
   4.3%
Anti-MAGE-A3, Week 120+6 months Number Analyzed 70 participants 36 participants
70
 100.0%
1
   2.8%
10.Secondary Outcome
Title Number of Subjects With Abnormal Haematological and Biochemical Parameters
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.
Time Frame Within the 31-day (Days 0-30) post-vaccination period, at follow-up analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 894 450
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Unknown - G0
3
   0.3%
2
   0.4%
ALT, Unknown - G1
1
   0.1%
0
   0.0%
ALT, Unknown - G2
0
   0.0%
0
   0.0%
ALT, Unknown - G3
0
   0.0%
0
   0.0%
ALT, Unknown - G4
0
   0.0%
0
   0.0%
ALT, Unknown - Unknown
2
   0.2%
0
   0.0%
ALT, G0 - G0
625
  69.9%
337
  74.9%
ALT, G0 - G1
98
  11.0%
30
   6.7%
ALT, G0 - G2
10
   1.1%
4
   0.9%
ALT, G0 - G3
3
   0.3%
4
   0.9%
ALT, G0 - G4
0
   0.0%
0
   0.0%
ALT, G0 - Unknown
36
   4.0%
18
   4.0%
ALT, G1 - G0
45
   5.0%
22
   4.9%
ALT, G1 - G1
49
   5.5%
25
   5.6%
ALT, G1 - G2
14
   1.6%
4
   0.9%
ALT, G1 - G3
1
   0.1%
2
   0.4%
ALT, G1 - G4
0
   0.0%
0
   0.0%
ALT, G1 - Unknown
2
   0.2%
1
   0.2%
ALT, G2 - G0
1
   0.1%
1
   0.2%
ALT, G2 - G1
2
   0.2%
0
   0.0%
ALT, G2 - G2
1
   0.1%
0
   0.0%
ALT, G2 - G3
0
   0.0%
0
   0.0%
ALT, G2 - G4
0
   0.0%
0
   0.0%
ALT, G2 - Unknown
0
   0.0%
0
   0.0%
ALT, G3 - G0
0
   0.0%
0
   0.0%
ALT, G3 - G1
0
   0.0%
0
   0.0%
ALT, G3 - G2
0
   0.0%
0
   0.0%
ALT, G3 - G3
0
   0.0%
0
   0.0%
ALT, G3 - G4
0
   0.0%
0
   0.0%
ALT, G3 - Unknown
1
   0.1%
0
   0.0%
ALT, Total - G0
674
  75.4%
362
  80.4%
ALT, Total - G1
150
  16.8%
55
  12.2%
ALT, Total - G2
25
   2.8%
8
   1.8%
ALT, Total - G3
4
   0.4%
6
   1.3%
ALT, Total - G4
0
   0.0%
0
   0.0%
ALT, Total - Unknown
41
   4.6%
19
   4.2%
AST, Unkown - G0
3
   0.3%
3
   0.7%
AST, Unkown - G1
1
   0.1%
0
   0.0%
AST, Unkown - G2
0
   0.0%
0
   0.0%
AST, Unkown - G3
0
   0.0%
0
   0.0%
AST, Unkown - G4
0
   0.0%
0
   0.0%
AST, Unkown - Unkown
3
   0.3%
0
   0.0%
AST, G0 - G0
701
  78.4%
356
  79.1%
AST, G0 - G1
88
   9.8%
37
   8.2%
AST, G0 - G2
5
   0.6%
3
   0.7%
AST, G0 - G3
3
   0.3%
4
   0.9%
AST, G0 - G4
0
   0.0%
0
   0.0%
AST, G0 - Unkown
40
   4.5%
19
   4.2%
AST, G1 - G0
24
   2.7%
15
   3.3%
AST, G1 - G1
18
   2.0%
11
   2.4%
AST, G1 - G2
3
   0.3%
1
   0.2%
AST, G1 - G3
2
   0.2%
0
   0.0%
AST, G1 - G4
0
   0.0%
0
   0.0%
AST, G1 - Unkown
1
   0.1%
1
   0.2%
AST, G2 - G0
0
   0.0%
0
   0.0%
AST, G2 - G1
0
   0.0%
0
   0.0%
AST, G2 - G2
1
   0.1%
0
   0.0%
AST, G2 - G3
0
   0.0%
0
   0.0%
AST, G2 - G4
0
   0.0%
0
   0.0%
AST, G2 - Unkown
1
   0.1%
0
   0.0%
AST, Total - G0
728
  81.4%
374
  83.1%
AST, Total - G1
107
  12.0%
48
  10.7%
AST, Total - G2
9
   1.0%
4
   0.9%
AST, Total - G3
5
   0.6%
4
   0.9%
AST, Total - G4
0
   0.0%
0
   0.0%
AST, Total - Unkown
45
   5.0%
20
   4.4%
AP, Unknown - G0
9
   1.0%
6
   1.3%
AP, Unknown - G1
0
   0.0%
1
   0.2%
AP, Unknown - G2
1
   0.1%
0
   0.0%
AP, Unknown - G3
0
   0.0%
0
   0.0%
AP, Unknown - G4
0
   0.0%
0
   0.0%
AP, Unknown - Unkown
2
   0.2%
0
   0.0%
AP, G0 - G0
749
  83.8%
378
  84.0%
AP, G0 - G1
56
   6.3%
18
   4.0%
AP, G0 - G2
3
   0.3%
4
   0.9%
AP, G0 - G3
2
   0.2%
1
   0.2%
AP, G0 - G4
0
   0.0%
0
   0.0%
AP, G0 - Unknown
38
   4.3%
18
   4.0%
AP, G1 - G0
18
   2.0%
13
   2.9%
AP, G1 - G1
14
   1.6%
9
   2.0%
AP, G1 - G2
0
   0.0%
0
   0.0%
AP, G1 - G3
0
   0.0%
0
   0.0%
AP, G1 - G4
0
   0.0%
0
   0.0%
AP, G1 - Unknown
2
   0.2%
2
   0.4%
AP, Total - G0
776
  86.8%
397
  88.2%
AP, Total - G1
70
   7.8%
28
   6.2%
AP, Total - G2
4
   0.4%
4
   0.9%
AP, Total - G3
2
   0.2%
1
   0.2%
AP, Total - G4
0
   0.0%
0
   0.0%
AP, Total - Unknown
42
   4.7%
20
   4.4%
BIL, Unknown - G0
7
   0.8%
5
   1.1%
BIL, Unknown - G1
1
   0.1%
0
   0.0%
BIL, Unknown - G2
0
   0.0%
0
   0.0%
BIL, Unknown - G3
0
   0.0%
0
   0.0%
BIL, Unknown - G4
0
   0.0%
0
   0.0%
BIL, Unknown - Unknown
1
   0.1%
1
   0.2%
BIL, G0 - G0
771
  86.2%
383
  85.1%
BIL, G0 - G1
33
   3.7%
21
   4.7%
BIL, G0 - G2
3
   0.3%
2
   0.4%
BIL, G0 - G3
0
   0.0%
1
   0.2%
BIL, G0 - G4
0
   0.0%
0
   0.0%
BIL,G 0 - Unknown
44
   4.9%
19
   4.2%
BIL, G1 -G 0
11
   1.2%
3
   0.7%
BIL, G1 - G1
10
   1.1%
5
   1.1%
BIL, G1 -G 2
9
   1.0%
4
   0.9%
BIL, G1 - G3
0
   0.0%
0
   0.0%
BIL, G1 - G4
0
   0.0%
0
   0.0%
BIL, G1 - Unkown
3
   0.3%
2
   0.4%
BIL, G2 - G0
0
   0.0%
0
   0.0%
BIL, G2 - G1
0
   0.0%
2
   0.4%
BIL, G2 - G2
0
   0.0%
2
   0.4%
BIL, G2 - G3
0
   0.0%
0
   0.0%
BIL, G2 - G4
0
   0.0%
0
   0.0%
BIL, G2 - Unknown
1
   0.1%
0
   0.0%
BIL, Total - G0
789
  88.3%
391
  86.9%
BIL, Total - G1
44
   4.9%
28
   6.2%
BIL, Total - G2
12
   1.3%
8
   1.8%
BIL, Total - G3
0
   0.0%
1
   0.2%
BIL, Total - G4
0
   0.0%
0
   0.0%
BIL, Total - Unknown
49
   5.5%
22
   4.9%
CREA, Unknown - G0
2
   0.2%
1
   0.2%
CREA, Unknown - G1
0
   0.0%
0
   0.0%
CREA, Unknown - G2
0
   0.0%
0
   0.0%
CREA, Unknown - G3
0
   0.0%
0
   0.0%
CREA, Unknown - G4
0
   0.0%
0
   0.0%
CREA, Unknown - Unknown
1
   0.1%
0
   0.0%
CREA, G0 - G0
789
  88.3%
391
  86.9%
CREA, G0 - G1
31
   3.5%
19
   4.2%
CREA, G0 - G2
0
   0.0%
1
   0.2%
CREA, G0 - G3
0
   0.0%
1
   0.2%
CREA, G0 - G4
0
   0.0%
0
   0.0%
CREA, G0 - Unknown
36
   4.0%
19
   4.2%
CREA, G1 - G0
8
   0.9%
6
   1.3%
CREA, G1 - G1
19
   2.1%
12
   2.7%
CREA, G1 - G2
3
   0.3%
0
   0.0%
CREA, G1 - G3
0
   0.0%
0
   0.0%
CREA, G1 - G4
0
   0.0%
0
   0.0%
CREA, G1 - Unknown
4
   0.4%
0
   0.0%
CREA, G2 - G0
0
   0.0%
0
   0.0%
CREA, G2 - G1
0
   0.0%
0
   0.0%
CREA, G2 - G2
1
   0.1%
0
   0.0%
CREA, G2 - G3
0
   0.0%
0
   0.0%
CREA, G2 - G4
0
   0.0%
0
   0.0%
CREA, G2 - Unknown
0
   0.0%
0
   0.0%
CREA, Total - G0
799
  89.4%
398
  88.4%
CREA, Total - G1
50
   5.6%
31
   6.9%
CREA, Total - G2
4
   0.4%
1
   0.2%
CREA, Total - G3
0
   0.0%
1
   0.2%
CREA, Total - G4
0
   0.0%
0
   0.0%
CREA, Total - Unknown
41
   4.6%
19
   4.2%
HGB, Unknown - G0
2
   0.2%
1
   0.2%
HGB, Unknown - G1
1
   0.1%
0
   0.0%
HGB, Unknown - G2
0
   0.0%
0
   0.0%
HGB, Unknown - G3
0
   0.0%
0
   0.0%
HGB, Unknown - G4
0
   0.0%
0
   0.0%
HGB, Unknown - Unknown
0
   0.0%
0
   0.0%
HGB, G0 - G0
636
  71.1%
326
  72.4%
HGB, G0 - G1
78
   8.7%
28
   6.2%
HGB, G0 - G2
7
   0.8%
3
   0.7%
HGB, G0 - G3
2
   0.2%
1
   0.2%
HGB, G0 - G4
0
   0.0%
0
   0.0%
HGB, G0 - Unknown
35
   3.9%
17
   3.8%
HGB, G1 - G0
39
   4.4%
27
   6.0%
HGB, G1 - G1
77
   8.6%
41
   9.1%
HGB, G1 - G2
7
   0.8%
2
   0.4%
HGB, G1 - G3
1
   0.1%
0
   0.0%
HGB, G1 - G4
1
   0.1%
0
   0.0%
HGB, G1 - Unknown
4
   0.4%
3
   0.7%
HGB, G2 - G0
1
   0.1%
1
   0.2%
HGB, G2 - G1
1
   0.1%
0
   0.0%
HGB, G2 - G2
2
   0.2%
0
   0.0%
HGB, G2 - G3
0
   0.0%
0
   0.0%
HGB, G2 - G4
0
   0.0%
0
   0.0%
HGB, G2 - Unknown
0
   0.0%
0
   0.0%
HGB, Total - G0
678
  75.8%
355
  78.9%
HGB, Total - G1
157
  17.6%
69
  15.3%
HGB, Total - G2
16
   1.8%
5
   1.1%
HGB, Total - G3
3
   0.3%
1
   0.2%
HGB, Total - G4
1
   0.1%
0
   0.0%
HGB, Total - Unknown
39
   4.4%
20
   4.4%
LEU, Unknown - G0
2
   0.2%
1
   0.2%
LEU, Unknown - G1
1
   0.1%
0
   0.0%
LEU, Unknown - G2
0
   0.0%
0
   0.0%
LEU, Unknown - G3
0
   0.0%
0
   0.0%
LEU, Unknown - G4
0
   0.0%
0
   0.0%
LEU, Unknown - Unknown
0
   0.0%
0
   0.0%
LEU, G0 - G0
762
  85.2%
382
  84.9%
LEU, G0 - G1
53
   5.9%
31
   6.9%
LEU, G0 - G2
4
   0.4%
2
   0.4%
LEU, G0 - G3
0
   0.0%
0
   0.0%
LEU, G0 - G4
2
   0.2%
0
   0.0%
LEU, G0 - Unknown
39
   4.4%
18
   4.0%
LEU, G1 - G0
13
   1.5%
8
   1.8%
LEU, G1 - G1
15
   1.7%
6
   1.3%
LEU, G1 - G2
1
   0.1%
1
   0.2%
LEU, G1 - G3
0
   0.0%
0
   0.0%
LEU, G1 - G4
0
   0.0%
0
   0.0%
LEU, G1 - Unknown
0
   0.0%
1
   0.2%
LEU, G2 - G0
0
   0.0%
0
   0.0%
LEU, G2 - G1
1
   0.1%
0
   0.0%
LEU, G2 - G2
0
   0.0%
0
   0.0%
LEU, G2 - G3
1
   0.1%
0
   0.0%
LEU, G2 - G4
0
   0.0%
0
   0.0%
LEU, G2 - Unknown
0
   0.0%
0
   0.0%
LEU, Total - G0
777
  86.9%
391
  86.9%
LEU, Total - G1
70
   7.8%
37
   8.2%
LEU, Total - G2
5
   0.6%
3
   0.7%
LEU, Total - G3
1
   0.1%
0
   0.0%
LEU, Total - G4
2
   0.2%
0
   0.0%
LEU, Total - Unknown
39
   4.4%
19
   4.2%
LYMPH, Unknown - G0
8
   0.9%
1
   0.2%
LYMPH, Unknown - G1
2
   0.2%
2
   0.4%
LYMPH, Unknown - G2
0
   0.0%
0
   0.0%
LYMPH, Unknown - G3
0
   0.0%
0
   0.0%
LYMPH, Unknown - G4
0
   0.0%
0
   0.0%
LYMPH, Unknown - Unknown
0
   0.0%
0
   0.0%
LYMPH, G0 - G0
633
  70.8%
303
  67.3%
LYMPH, G0 - G1
93
  10.4%
57
  12.7%
LYMPH, G0 - G2
17
   1.9%
8
   1.8%
LYMPH, G0 - G3
4
   0.4%
0
   0.0%
LYMPH, G0 - G4
0
   0.0%
0
   0.0%
LYMPH, G0 - Unknown
38
   4.3%
22
   4.9%
LYMPH, G1 - G0
29
   3.2%
9
   2.0%
LYMPH, G1 - G1
49
   5.5%
37
   8.2%
LYMPH, G1 - G2
4
   0.4%
6
   1.3%
LYMPH, G1 - G3
4
   0.4%
0
   0.0%
LYMPH, G1 - G4
0
   0.0%
0
   0.0%
LYMPH, G1 - Unknown
4
   0.4%
0
   0.0%
LYMPH, G2 - G0
1
   0.1%
1
   0.2%
LYMPH, G2 - G1
4
   0.4%
1
   0.2%
LYMPH, G2 - G2
2
   0.2%
2
   0.4%
LYMPH, G2 - G3
2
   0.2%
0
   0.0%
LYMPH, G2 - G4
0
   0.0%
0
   0.0%
LYMPH, G2 - Unknown
0
   0.0%
0
   0.0%
LYMPH, G3 - G0
0
   0.0%
0
   0.0%
LYMPH, G3 - G1
0
   0.0%
1
   0.2%
LYMPH, G3 - G2
0
   0.0%
0
   0.0%
LYMPH, G3 - G3
0
   0.0%
0
   0.0%
LYMPH, G3 - G4
0
   0.0%
0
   0.0%
LYMPH, G3 - Unknown
0
   0.0%
0
   0.0%
LYMPH, Total - G0
671
  75.1%
314
  69.8%
LYMPH, Total - G1
148
  16.6%
98
  21.8%
LYMPH, Total - G2
23
   2.6%
16
   3.6%
LYMPH, Total - G3
10
   1.1%
0
   0.0%
LYMPH, Total - G4
0
   0.0%
0
   0.0%
LYMPH, Total - Unknown
42
   4.7%
22
   4.9%
NEU, Unknown - G0
6
   0.7%
1
   0.2%
NEU, Unknown - G1
0
   0.0%
1
   0.2%
NEU, Unknown - G2
0
   0.0%
0
   0.0%
NEU, Unknown - G3
0
   0.0%
0
   0.0%
NEU, Unknown - G4
0
   0.0%
0
   0.0%
NEU, Unknown - Unknown
0
   0.0%
0
   0.0%
NEU, G0 - G0
781
  87.4%
393
  87.3%
NEU, G0 - G1
39
   4.4%
16
   3.6%
NEU, G0 - G2
9
   1.0%
2
   0.4%
NEU, G0 - G3
0
   0.0%
0
   0.0%
NEU, G0 - G4
1
   0.1%
0
   0.0%
NEU, G0 - Unknown
43
   4.8%
22
   4.9%
NEU, G1 - G0
7
   0.8%
10
   2.2%
NEU, G1 - G1
6
   0.7%
3
   0.7%
NEU, G1 - G2
1
   0.1%
2
   0.4%
NEU, G1 - G3
0
   0.0%
0
   0.0%
NEU, G1 - G4
0
   0.0%
0
   0.0%
NEU, G1 - Unknown
0
   0.0%
0
   0.0%
NEU, G2 - G0
0
   0.0%
0
   0.0%
NEU, G2 - G1
1
   0.1%
0
   0.0%
NEU, G2 - G2
0
   0.0%
0
   0.0%
NEU, G2 - G3
0
   0.0%
0
   0.0%
NEU, G2 - G4
0
   0.0%
0
   0.0%
NEU, G2 - Unknown
0
   0.0%
0
   0.0%
NEU, Total - G0
794
  88.8%
404
  89.8%
NEU, Total - G1
46
   5.1%
20
   4.4%
NEU, Total - G2
10
   1.1%
4
   0.9%
NEU, Total - G3
0
   0.0%
0
   0.0%
NEU, Total - G4
1
   0.1%
0
   0.0%
NEU, Total - Unknown
43
   4.8%
22
   4.9%
PLA, Unknown - G0
4
   0.4%
1
   0.2%
PLA, Unknown - G1
0
   0.0%
0
   0.0%
PLA, Unknown - G2
0
   0.0%
0
   0.0%
PLA, Unknown - G3
0
   0.0%
0
   0.0%
PLA, Unknown - G4
0
   0.0%
0
   0.0%
PLA, Unknown - Unknown
0
   0.0%
0
   0.0%
PLA, G0 - G0
796
  89.0%
390
  86.7%
PLA, G0 - G1
34
   3.8%
25
   5.6%
PLA, G0 - G2
0
   0.0%
1
   0.2%
PLA, G0 - G3
0
   0.0%
0
   0.0%
PLA, G0 - G4
1
   0.1%
3
   0.7%
PLA, G0 - Unknown
36
   4.0%
17
   3.8%
PLA, G1 - G0
4
   0.4%
1
   0.2%
PLA, G1 - G1
15
   1.7%
10
   2.2%
PLA, G1 - G2
1
   0.1%
0
   0.0%
PLA, G1 - G3
0
   0.0%
0
   0.0%
PLA, G1 - G4
0
   0.0%
0
   0.0%
PLA, G1 - Unknown
3
   0.3%
2
   0.4%
PLA, Total - G0
804
  89.9%
392
  87.1%
PLA, Total - G1
49
   5.5%
35
   7.8%
PLA, Total - G2
1
   0.1%
1
   0.2%
PLA, Total - G3
0
   0.0%
0
   0.0%
PLA, Total - G4
1
   0.1%
3
   0.7%
PLA, Total - Unknown
39
   4.4%
19
   4.2%
11.Secondary Outcome
Title Number of Subjects With Any Adverse Events (AEs)
Hide Description 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.
Time Frame Within the 31-day (Days 0-30) follow-up period after vaccination - at Follow-up analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 894 450
Measure Type: Count of Participants
Unit of Measure: Participants
822
  91.9%
334
  74.2%
12.Secondary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Day 0 up to study end (Year 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 894 450
Measure Type: Count of Participants
Unit of Measure: Participants
129
  14.4%
64
  14.2%
13.Secondary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame Within the 31-day (Days 0-30) post-administration period, at Follow-up analysis
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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.
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.
Overall Number of Participants Analyzed 894 450
Measure Type: Count of Participants
Unit of Measure: Participants
33
   3.7%
23
   5.1%
Time Frame Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after vaccination. Serious Adverse Events: from Day 0 up to study end, at Year 5.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MAGE-A3 Group Placebo Group
Hide Arm/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. 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.
All-Cause Mortality
MAGE-A3 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   5/894 (0.56%)      1/450 (0.22%)    
Show Serious Adverse Events Hide Serious Adverse Events
MAGE-A3 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   129/894 (14.43%)      64/450 (14.22%)    
Blood and lymphatic system disorders     
Anaemia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Disseminated intravascular coagulation  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Haemolytic uraemic syndrome  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Leukopenia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymphadenitis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymphadenopathy  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Neutropenia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Thrombocytopenia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Thrombocytopenic purpura  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Cardiac disorders     
Angina pectoris  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Atrioventricular block  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Atrioventricular block second degree  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Bradycardia  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Cardiac arrest  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Cardiac failure  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Cardiac failure acute  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Coronary artery disease  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Intracardiac thrombus  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Ischaemic cardiomyopathy  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Left ventricular failure  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Myocardial infarction  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Myocardial ischaemia  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Vertigo positional  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Endocrine disorders     
Autoimmune thyroiditis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Basedow’s disease  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymphocytic hypophysitis  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Polyglandular autoimmune syndrome type ii  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Eye disorders     
Retinal detachment  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Retinal vascular thrombosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Retinopathy  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Vision blurred  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Diverticulum  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Dysphagia  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Ileal perforation  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Inguinal hernia  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Large intestine perforation  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Nausea  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Pancreatitis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Umbilical hernia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Vomiting  1  1/894 (0.11%)  1 0/450 (0.00%)  0
General disorders     
Chest pain  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Device dislocation  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Impaired healing  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Oedema peripheral  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Pyrexia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Bile duct obstruction  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Bile duct stone  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Cholecystitis chronic  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Cholelithiasis  1  0/894 (0.00%)  0 2/450 (0.44%)  2
Hepatic steatosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Hepatitis acute  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Hydrocholecystis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Jaundice  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Immune system disorders     
Sarcoidosis  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Infections and infestations     
Abscess limb  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Appendicitis  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Cellulitis  1  1/894 (0.11%)  1 5/450 (1.11%)  5
Cellulitis enterococcal  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Cystitis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Endocarditis bacterial  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Erysipelas  1  7/894 (0.78%)  9 5/450 (1.11%)  5
Escherichia urinary tract infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
H1n1 influenza  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Localised infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lung infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymph node abscess  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymphangitis  1  2/894 (0.22%)  2 1/450 (0.22%)  1
Pharyngitis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Pilonidal cyst  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Pneumonia haemophilus  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Post procedural infection  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Postoperative abscess  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Prostatitis escherichia coli  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Sepsis  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Streptococcal infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Subcutaneous abscess  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Urinary tract infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Urosepsis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Wound infection  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Injury, poisoning and procedural complications     
Asbestosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Contrast media reaction  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Electric shock  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Femur fracture  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Humerus fracture  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Patella fracture  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Periprosthetic fracture  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Post procedural fistula  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Post procedural haematoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Postoperative hernia  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Radius fracture  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Tendon rupture  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Tibia fracture  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Investigations     
Blood alkaline phosphatase increased  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Transaminases increased  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  2/894 (0.22%)  2 1/450 (0.22%)  1
Lumbar spinal stenosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Neck pain  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Osteoarthritis  1  2/894 (0.22%)  2 1/450 (0.22%)  1
Pain in extremity  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Synovial cyst  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  25/894 (2.80%)  34 13/450 (2.89%)  14
Bladder transitional cell carcinoma  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Clear cell renal cell carcinoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Endometrial adenocarcinoma  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Focal nodular hyperplasia  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Glioblastoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Invasive lobular breast carcinoma  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Lentigo maligna  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Lymphoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Malignant melanoma  1  9/894 (1.01%)  9 3/450 (0.67%)  3
Malignant melanoma in situ  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Malignant melanoma stage i  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Non-hodgkin’s lymphoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Papillary thyroid cancer  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Polycythaemia vera  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Porocarcinoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Prostate cancer  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Prostatic adenoma  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Renal cell carcinoma  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Squamous cell carcinoma of skin  1  6/894 (0.67%)  9 3/450 (0.67%)  3
Superficial spreading melanoma stage unspecified  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Thyroid cancer  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Urinary tract neoplasm  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Uterine leiomyoma  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Nervous system disorders     
Cerebral haemorrhage  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Cerebrovascular accident  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Meningism  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Multiple sclerosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Polyneuropathy  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Psychomotor skills impaired  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Subarachnoid haemorrhage  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Psychiatric disorders     
Major depression  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Mental disorder  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Mental status changes  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Suicide attempt  1  0/894 (0.00%)  0 1/450 (0.22%)  2
Renal and urinary disorders     
Bladder neck sclerosis  1  1/894 (0.11%)  2 0/450 (0.00%)  0
Nephrolithiasis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Renal failure  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Urinary retention  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  3/894 (0.34%)  3 0/450 (0.00%)  0
Organising pneumonia  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Pleural effusion  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Pulmonary embolism  1  2/894 (0.22%)  2 0/450 (0.00%)  0
Pulmonary oedema  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Respiratory failure  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Vocal cord polyp  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Skin and subcutaneous tissue disorders     
Actinic elastosis  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Dermal cyst  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Vascular disorders     
Aortic aneurysm  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Deep vein thrombosis  1  2/894 (0.22%)  2 1/450 (0.22%)  1
Haematoma  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Hypertension  1  1/894 (0.11%)  1 1/450 (0.22%)  1
Intermittent claudication  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Lymphocele  1  0/894 (0.00%)  0 1/450 (0.22%)  1
Lymphoedema  1  1/894 (0.11%)  1 0/450 (0.00%)  0
Peripheral arterial occlusive disease  1  1/894 (0.11%)  2 0/450 (0.00%)  0
Thrombosis  1  0/894 (0.00%)  0 1/450 (0.22%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MAGE-A3 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   819/894 (91.61%)      327/450 (72.67%)    
Gastrointestinal disorders     
Diarrhoea  1  46/894 (5.15%)  61 19/450 (4.22%)  26
Nausea  1  123/894 (13.76%)  266 32/450 (7.11%)  43
General disorders     
Asthenia  1  149/894 (16.67%)  354 46/450 (10.22%)  68
Chills  1  179/894 (20.02%)  432 15/450 (3.33%)  23
Fatigue  1  210/894 (23.49%)  490 63/450 (14.00%)  116
Influenza like illness  1  261/894 (29.19%)  902 30/450 (6.67%)  46
Injection site erythema  1  90/894 (10.07%)  241 3/450 (0.67%)  3
Injection site oedema  1  48/894 (5.37%)  134 3/450 (0.67%)  5
Injection site pain  1  325/894 (36.35%)  1057 22/450 (4.89%)  37
Injection site reaction  1  160/894 (17.90%)  500 6/450 (1.33%)  9
Pain  1  191/894 (21.36%)  480 19/450 (4.22%)  26
Pyrexia  1  380/894 (42.51%)  1240 35/450 (7.78%)  44
Musculoskeletal and connective tissue disorders     
Arthralgia  1  84/894 (9.40%)  165 31/450 (6.89%)  43
Myalgia  1  188/894 (21.03%)  456 23/450 (5.11%)  39
Pain in extremity  1  115/894 (12.86%)  207 26/450 (5.78%)  28
Nervous system disorders     
Headache  1  205/894 (22.93%)  550 55/450 (12.22%)  128
Skin and subcutaneous tissue disorders     
Erythema  1  138/894 (15.44%)  297 10/450 (2.22%)  10
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
The study was terminated early on 08 Sep 2015 following assessment of the two co-primary endpoints showed the lack of efficacy of the study product.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00796445     History of Changes
Other Study ID Numbers: 111482
2008-002447-16 ( EudraCT Number )
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: September 30, 2016
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019