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

• ClinicalTrials.gov Identifier: NCT00796445
• Recruitment Status: Terminated
• First Posted: November 24, 2008
• Results First Posted: March 19, 2019
• Last Update Posted: March 5, 2021
• Sponsor: GlaxoSmithKline
• 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

Participant Flow

Recruitment Details

Pre-assignment Details

Out of 1351 patients enrolled in the study, 6 patients did not receive treatment and were excluded from study start, hence 1345 patients were included in the Total treated population-as treated (895 in the MAGE-A3 Group and 450 in the Placebo Group). 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, which included 1344 patients: 894 in the MAGE-A3 Group and 450 in the Placebo Group.

Arm/Group Title	MAGE-A3 Group	Placebo Group
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	895	450
Completed	310	158
Not Completed	585	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
Invalid Informed Consent Form	1	0

Baseline Characteristics

Arm/Group Title		MAGE-A3 Group	Placebo Group	Total
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1. Primary Outcome

Title	Disease Free Survival (DFS)
Description	DFS = time to event 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 person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), 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)

Outcome Measure Data

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
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: First events per person-year
	0.505	0.478	0.500	0.460	0.437	0.442

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]

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]

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)
Description	DFS = time to event 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 person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), 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)

Outcome Measure Data

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
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: First events per person-year
	0.366	0.345	0.345	0.335	0.316	0.319

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]

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]

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)
Description	Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.
Time Frame	At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)

Outcome Measure Data

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
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: Events per person-year
OS, Final analysis	Number Analyzed	893 participants	452 participants	200 participants	116 participants	255 participants	126 participants
		0.177	0.165	0.172	0.188	0.165	0.151
OS, Follow-up analysis	Number Analyzed	892 participants	452 participants	200 participants	116 participants	255 participants	126 participants
		0.146	0.140	0.146	0.153	0.132	0.120

4. Secondary Outcome

Title	Disease-free Specific Survival (DFSS)
Description	Disease Free Specific Survival (DFSS) was defined as the time to event 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 person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), 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)

Outcome Measure Data

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
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: First events per person-year
	0.499	0.478	0.500	0.460	0.434	0.442

5. Secondary Outcome

Title	Distant Metastasis-free Survival (DMFS)
Description	Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), 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)

Outcome Measure Data

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
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: First events per person-year
	0.387	0.342	0.388	0.337	0.334	0.307

6. Secondary Outcome

Title	Health-related Quality of Life
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration.
Time Frame	At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months

Outcome Measure Data

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
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
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-treatment period

Outcome Measure Data

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
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, Unknown - G0	3 0.3%	3 0.7%
AST, Unknown - G1	1 0.1%	0 0.0%
AST, Unknown - G2	0 0.0%	0 0.0%
AST, Unknown - G3	0 0.0%	0 0.0%
AST, Unknown - G4	0 0.0%	0 0.0%
AST, Unknown - Unknown	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 - Unknown	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 - Unknown	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 - Unknown	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 - Unknown	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 - Unknown	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 - Unknown	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)
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 treatment

Outcome Measure Data

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
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	895	450
Measure Type: Count of Participants; Unit of Measure: Participants
	822 91.8%	333 74.0%

12. Secondary Outcome

Title	Number of Subjects With Any Serious Adverse Events (SAEs)
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 (up to 5 years)

Outcome Measure Data

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
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	895	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)
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	From Day 0 up to study end (up to 5 years)

Outcome Measure Data

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
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	895	450
Measure Type: Count of Participants; Unit of Measure: Participants
	33 3.7%	23 5.1%

Adverse Events

Time Frame	Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MAGE-A3 Group		Placebo Group
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	5/895 (0.56%)		1/450 (0.22%)
Serious Adverse Events
	MAGE-A3 Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	129/895 (14.41%)		64/450 (14.22%)
Blood and lymphatic system disorders
Anaemia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Disseminated intravascular coagulation † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Haemolytic uraemic syndrome † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Leukopenia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymphadenitis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymphadenopathy † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Neutropenia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Thrombocytopenia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Thrombocytopenic purpura † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Cardiac disorders
Angina pectoris † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Atrioventricular block † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Atrioventricular block second degree † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Bradycardia † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Cardiac arrest † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Cardiac failure † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Cardiac failure acute † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Coronary artery disease † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Intracardiac thrombus † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Ischaemic cardiomyopathy † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Left ventricular failure † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Myocardial infarction † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Myocardial ischaemia † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Ear and labyrinth disorders
Vertigo † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Vertigo positional † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Endocrine disorders
Autoimmune thyroiditis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Basedow's disease † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymphocytic hypophysitis † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Polyglandular autoimmune syndrome type ii † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Eye disorders
Retinal detachment † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Retinal vascular thrombosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Retinopathy † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Vision blurred † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Diverticulum † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Dysphagia † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Ileal perforation † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Inguinal hernia † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Large intestine perforation † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Nausea † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Pancreatitis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Umbilical hernia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Vomiting † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
General disorders
Chest pain † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Device dislocation † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Impaired healing † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Oedema peripheral † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Pyrexia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Hepatobiliary disorders
Autoimmune hepatitis † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Bile duct obstruction † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Bile duct stone † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Cholecystitis chronic † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Cholelithiasis † 1	0/895 (0.00%)	0	2/450 (0.44%)	2
Hepatic steatosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Hepatitis acute † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Hydrocholecystis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Jaundice † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Immune system disorders
Sarcoidosis † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Infections and infestations
Abscess limb † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Appendicitis † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Cellulitis † 1	1/895 (0.11%)	1	5/450 (1.11%)	5
Cellulitis enterococcal † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Cystitis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Endocarditis bacterial † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Erysipelas † 1	7/895 (0.78%)	9	5/450 (1.11%)	5
Escherichia urinary tract infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
H1n1 influenza † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Localised infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lung infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymph node abscess † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymphangitis † 1	2/895 (0.22%)	2	1/450 (0.22%)	1
Pharyngitis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Pilonidal cyst † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Pneumonia haemophilus † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Post procedural infection † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Postoperative abscess † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Prostatitis escherichia coli † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Sepsis † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Streptococcal infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Subcutaneous abscess † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Urinary tract infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Urosepsis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Wound infection † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Injury, poisoning and procedural complications
Asbestosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Contrast media reaction † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Electric shock † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Femur fracture † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Humerus fracture † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Patella fracture † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Periprosthetic fracture † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Post procedural fistula † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Post procedural haematoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Postoperative hernia † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Radius fracture † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Tendon rupture † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Tibia fracture † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Investigations
Blood alkaline phosphatase increased † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Gamma-glutamyltransferase increased † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Transaminases increased † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Metabolism and nutrition disorders
Dehydration † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain † 1	2/895 (0.22%)	2	1/450 (0.22%)	1
Lumbar spinal stenosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Neck pain † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Osteoarthritis † 1	2/895 (0.22%)	2	1/450 (0.22%)	1
Pain in extremity † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Synovial cyst † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	25/895 (2.79%)	34	13/450 (2.89%)	14
Bladder transitional cell carcinoma † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Clear cell renal cell carcinoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Endometrial adenocarcinoma † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Focal nodular hyperplasia † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Glioblastoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Invasive lobular breast carcinoma † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Lentigo maligna † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Lymphoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Malignant melanoma † 1	9/895 (1.01%)	9	3/450 (0.67%)	3
Malignant melanoma in situ † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Malignant melanoma stage i † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Non-hodgkin's lymphoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Papillary thyroid cancer † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Polycythaemia vera † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Porocarcinoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Prostate cancer † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Prostatic adenoma † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Renal cell carcinoma † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Squamous cell carcinoma of skin † 1	6/895 (0.67%)	9	3/450 (0.67%)	3
Superficial spreading melanoma stage unspecified † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Thyroid cancer † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Urinary tract neoplasm † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Uterine leiomyoma † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Nervous system disorders
Cerebral haemorrhage † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Cerebrovascular accident † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Meningism † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Multiple sclerosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Polyneuropathy † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Psychomotor skills impaired † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Subarachnoid haemorrhage † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Psychiatric disorders
Major depression † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Mental disorder † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Mental status changes † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Suicide attempt † 1	0/895 (0.00%)	0	1/450 (0.22%)	2
Renal and urinary disorders
Bladder neck sclerosis † 1	1/895 (0.11%)	2	0/450 (0.00%)	0
Nephrolithiasis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Renal failure † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Urinary retention † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Reproductive system and breast disorders
Ovarian cyst † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease † 1	3/895 (0.34%)	3	0/450 (0.00%)	0
Organising pneumonia † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Pleural effusion † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Pulmonary embolism † 1	2/895 (0.22%)	2	0/450 (0.00%)	0
Pulmonary oedema † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Respiratory failure † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Vocal cord polyp † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Skin and subcutaneous tissue disorders
Actinic elastosis † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Dermal cyst † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Vascular disorders
Aortic aneurysm † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Deep vein thrombosis † 1	2/895 (0.22%)	2	1/450 (0.22%)	1
Haematoma † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Hypertension † 1	1/895 (0.11%)	1	1/450 (0.22%)	1
Intermittent claudication † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Lymphocele † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
Lymphoedema † 1	1/895 (0.11%)	1	0/450 (0.00%)	0
Peripheral arterial occlusive disease † 1	1/895 (0.11%)	2	0/450 (0.00%)	0
Thrombosis † 1	0/895 (0.00%)	0	1/450 (0.22%)	1
1 Term from vocabulary, MedDRA 18.1; † Indicates events were collected by systematic assessment
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	819/895 (91.51%)		327/450 (72.67%)
Gastrointestinal disorders
Diarrhoea † 1	46/895 (5.14%)	61	19/450 (4.22%)	26
Nausea † 1	123/895 (13.74%)	266	32/450 (7.11%)	43
General disorders
Asthenia † 1	149/895 (16.65%)	354	46/450 (10.22%)	68
Chills † 1	179/895 (20.00%)	432	15/450 (3.33%)	23
Fatigue † 1	210/895 (23.46%)	490	63/450 (14.00%)	116
Influenza like illness † 1	261/895 (29.16%)	902	30/450 (6.67%)	46
Injection site erythema † 1	90/895 (10.06%)	241	3/450 (0.67%)	3
Injection site oedema † 1	48/895 (5.36%)	134	3/450 (0.67%)	5
Injection site pain † 1	325/895 (36.31%)	1057	22/450 (4.89%)	37
Injection site reaction † 1	160/895 (17.88%)	500	6/450 (1.33%)	9
Pain † 1	191/895 (21.34%)	480	19/450 (4.22%)	26
Pyrexia † 1	380/895 (42.46%)	1240	35/450 (7.78%)	44
Musculoskeletal and connective tissue disorders
Arthralgia † 1	84/895 (9.39%)	165	31/450 (6.89%)	43
Myalgia † 1	188/895 (21.01%)	456	23/450 (5.11%)	39
Pain in extremity † 1	115/895 (12.85%)	207	26/450 (5.78%)	28
Nervous system disorders
Headache † 1	205/895 (22.91%)	550	55/450 (12.22%)	128
Skin and subcutaneous tissue disorders
Erythema † 1	138/895 (15.42%)	297	10/450 (2.22%)	10
1 Term from vocabulary, MedDRA 18.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

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.

More Information

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

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

Publications:

Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.

Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00796445
• 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 5, 2021