Immunotherapy of Stage III/IV Melanoma Patients

Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00112242

Enrollment

Registered

2005-06-01

Start date

2004-02-29

Completion date

2013-03-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, MAGE-A10 peptide, NY-ESO-1 peptide, Montanide, CpG

Brief summary

The purpose of this study is to determine whether vaccination with melanoma antigen peptides \[Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10\] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Detailed description

Current peptide vaccines suffer from low efficiency, since they induce only weak immune activation. We have recently confirmed that in humans the immune response was readily detectable in local lymph nodes while no or only weak activation could be identified in circulating lymphocytes. Increased doses of antigen and adjuvant allow a better extension from local to systemic immune responses. * Group 1 : vaccination with Melan-A analog (ELA) peptide + Montanide * Group 2 : vaccination with Melan-A analog (ELA), NY-ESO-1b analog and MAGE-A10 peptides + Montanide * Group 3: vaccination with Melan-A analog (both EAA and ELA), Mage-A10, NY-ESO-1 peptides+ Montanide + CpG adjuvant * Group 4: vaccination with Melan-A (ELA), Mage-A10,long NY-ESO-1LP peptides + Montanide + CpG * Group 5: vaccination with Melan-A (both EAA and ELA), Mage-A10, long NY-ESO-1 LP peptides + Montanide + CpG + low dose rIL-2

Interventions

BIOLOGICALMelan-A ELA + Montanide

A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received booster vaccinations every 3 months.

BIOLOGICALMelan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide

BIOLOGICALMelan-A -ELA + NY-ESO-1b + MAGE-A10 peptide + Montanide + CpG

BIOLOGICALMelan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG

BIOLOGICALMelan-A-EAA/ELA + NY-ESO-1 lp + MAGE-A10 + Montanide + CpG+ IL-2

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed stage III or stage IV melanoma with at least one metastatic lymph node and/or at least one in-transit metastasis. According to the AJCC rules, this includes all patients with stage IV and stage III. Patients with or without measurable disease may be included. 2. Tumor expression of Melan-A by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis for patients of group I. Tumor expression of Melan-A and at least one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1 by rt-PCR analysis for patients of group II and III and for HLA-A2+ patients of groups IV and V. HLA-A2 negative patients of groups IV and V must only have NY-ESO-1 positive tumors to be eligible, while expression of Melan-A and MAGE-A10 is unimportant. If no frozen tissue is available, immunohistochemistry may be performed to detect tumor expression of Melan-A and NY-ESO-1. 3. HLA-A2 positive (serological or molecular typing of Peripheral Blood Lymphocytes (PBL) for patients of groups 1 to 3. Patients of groups 4 and 5 may either be HLA-A2+ or HLA-A2-. 4. Expected survival of at least five months. 5. Full recovery from surgery. 6. Karnofsky scale performance status of 70% or more. 7. The following laboratory results: Neutrophil count sup or equal 2.0 x 10\^9/L Lymphocyte count sup or equal 0.5 x 10\^9/L Platelet count sup or equal 100 x 10\^9/L Creatinine ≤ 2 mg/dL (180 micromol/L) Bilirubin ≤ 2mg/dL (34 micromol/L) Granulocyte count \> 2.5x10\^9/L AST \< 2x upper limit of normal aPTT: within the normal ranges of the laboratory ± 25 % 8. Age \> 18 years. 9. Able to give written informed consent.

Exclusion criteria

1. Clinically significant heart disease (NYHA Class III or IV). 2. Other serious illnesses, e.g., serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders with major dysfunction. 3. History of immunodeficiency disease or autoimmune disease. 4. Known HIV positivity. 5. Known seropositivity for hepatitis B surface antigen. 6. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). 7. Concomitant treatment with steroids, antihistamine drugs. Topical or inhalational steroids are permitted. 8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 9. Pregnancy or lactation. 10. Women of childbearing potential not using a medically acceptable means of contraception. 11. Psychiatric or addictive disorders that may compromise the ability to give informed consent. 12. Lack of availability of the patient for immunological and clinical follow-up assessment. 13. Coagulation or bleeding disorders. 14. Metastatic disease to the central nervous system, unless treated and stable.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD8+ T cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	For each patient, total CD8+ T cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD8+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	Change from baseline to end of Cycle 1 (3 months), end of Cycle 2 (8 months), end of Cycle 3 (13 months) and end of Boost Cycles (18 months to 23 months).	Safety of the vaccination was assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale. The adverse events (AE) and serious adverse events (SAE) were registered at each study visit during the 3 vaccination cycles and boost cycles.
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Fold change from baseline in Melan-A-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months).	Ex vivo frequency of Melan-A-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: Melan-A-specific CD8+ T cell frequency at the time point/ Melan-A-specific CD8+ T cell frequency at baseline. Significant T cell response is defined by at least 2-fold change of Melan-A-specific CD8+ T cell frequency as compared to pre-immunotherapy.
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Fold change from baseline in Melan-A-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	Ex vivo frequency of Melan-A-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	Fold change from baseline in NY-ESO-1-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	Ex vivo frequency of NY-ESO-1-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific CD8+ T cell frequency at the time point/ NY-ESO-1-specific CD8+ T cell frequency at baseline.
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Fold change from baseline in NY-ESO-1-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	Ex vivo frequency of NY-ESO-1-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	Fold change from baseline in MAGE-A10-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	Ex vivo frequency of MAGE-A10-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific CD8+ T cell frequency at the time point/ MAGE-A10-specific CD8+ T cell frequency at baseline.
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Fold change from baseline in MAGE-A10-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	Ex vivo frequency of MAGE-A10-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)	For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.

Secondary

Measure	Time frame	Description
Disease Status Assessment During the Vaccination Period	Disease status at baseline, after cycle 1 (3 months), after cycle 2 (8 months), after cycle 3 (13 months) and if applicable after boost cycles (16 months, 19 months or 22 months)	The disease status was assessed by computed tomography (CT) or positron emission tomography (PET)/CT at baseline and after the fourth vaccination of each cycle. During the booster vaccines period, imagery examinations were performed every 3 months for patients with measurable disease and every 6 months for patients with non measurable disease. The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as: * No Evidence of Disease (NED) * Stable disease (SD): Change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion. * Progressing disease (PD): Appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter.

Countries

Switzerland

Participant flow

Recruitment details

Subjects were screened and enrolled at 2 sites in Switzerland, the CHUV in Lausanne and the HUG in Geneva.

Pre-assignment details

The assignment to a group was done according to tumor antigen (i.e., Melan-A, MAGE-A10, NY-ESO-1b\[A\]) and HLA expression (HLA-A2).

Participants by arm

Arm	Count
Single Peptide Vaccination Montanide + Melan-A analogue peptide Montanide + Melan-A analogue peptide: 1 ml Montanide+ 500 mcg Melan-A analog peptide	10
Peptide Combination Vaccination Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide	5
Peptide Combination Vaccination + CpG Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide + 500 mcg Mage10 peptide	5
Native and Analog Peptide Combination Vaccination + CpG Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide	10
Native and Analog Peptide Combination Vaccination + CpG + IL-2 Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2 Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2	8
Total	38

Baseline characteristics

Characteristic	Peptide Combination Vaccination	Peptide Combination Vaccination + CpG	Native and Analog Peptide Combination Vaccination + CpG	Single Peptide Vaccination	Native and Analog Peptide Combination Vaccination + CpG + IL-2	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	2 Participants	2 Participants	2 Participants	4 Participants	2 Participants	12 Participants
Age, Categorical Between 18 and 65 years	3 Participants	3 Participants	8 Participants	6 Participants	6 Participants	26 Participants
Age, Continuous	58.8 years	64.9 years	59.9 years	61.8 years	59.2 years	60.1 years
Region of Enrollment Switzerland	5 Participants	5 Participants	10 Participants	10 Participants	8 Participants	38 Participants
Sex: Female, Male Female	2 Participants	2 Participants	2 Participants	3 Participants	3 Participants	12 Participants
Sex: Female, Male Male	3 Participants	3 Participants	8 Participants	7 Participants	5 Participants	26 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 5	0 / 5	0 / 10	0 / 9
other Total, other adverse events	10 / 10	5 / 5	5 / 5	10 / 10	9 / 9
serious Total, serious adverse events	1 / 10	1 / 5	1 / 5	3 / 10	2 / 9

Outcome results

Primary

Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)

Safety of the vaccination was assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale. The adverse events (AE) and serious adverse events (SAE) were registered at each study visit during the 3 vaccination cycles and boost cycles.

Time frame: Change from baseline to end of Cycle 1 (3 months), end of Cycle 2 (8 months), end of Cycle 3 (13 months) and end of Boost Cycles (18 months to 23 months).

Population: After the end of a cycle, patients could have discontinue the study for personal reasons or PD. This is why the overall number of patients analyzed could change between cycles of each arm/group.

Arm	Measure	Group	Value (MEAN)	Dispersion
1.Melan-A ELA	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 3	6.20 Number of adverse events	Standard Deviation 4.2
1.Melan-A ELA	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 2	10.44 Number of adverse events	Standard Deviation 7.46
1.Melan-A ELA	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	Boot cycles	8.50 Number of adverse events	Standard Deviation 6.54
1.Melan-A ELA	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 1	13.40 Number of adverse events	Standard Deviation 13.02
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	Boot cycles	9.00 Number of adverse events	Standard Deviation 5.81
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 3	16.00 Number of adverse events	Standard Deviation 9.74
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 1	18.40 Number of adverse events	Standard Deviation 5.86
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 2	10.00 Number of adverse events	Standard Deviation 7.62
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 1	23.80 Number of adverse events	Standard Deviation 12.15
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	Boot cycles	48.67 Number of adverse events	Standard Deviation 53.87
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 2	20.25 Number of adverse events	Standard Deviation 13.33
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 3	21.25 Number of adverse events	Standard Deviation 12.1
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	Boot cycles	50 Number of adverse events	Standard Deviation 0
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 2	21.00 Number of adverse events	Standard Deviation 12.3
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 1	19.60 Number of adverse events	Standard Deviation 8.15
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 3	19.67 Number of adverse events	Standard Deviation 12.92
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 2	16.80 Number of adverse events	Standard Deviation 10.45
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 1	31.75 Number of adverse events	Standard Deviation 18.92
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)	End of Cycle 3	20.50 Number of adverse events	Standard Deviation 9.61

Primary

Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period

Ex vivo frequency of MAGE-A10-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific CD8+ T cell frequency at the time point/ MAGE-A10-specific CD8+ T cell frequency at baseline.

Time frame: Fold change from baseline in MAGE-A10-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: This test was only done in patients MAGE-A10 positive and HLA-A2 positive (groups 2 and 3, some patients from groups 4 and 5)

Arm	Measure	Group	Value (MEAN)	Dispersion
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.02 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.01
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.03 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.03
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.03 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.02
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.02 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.02
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	Baseline	0 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	Baseline	0 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.07 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.07
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.03 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.02
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.05 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.05
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.03 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.02
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	Baseline	0 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.03 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.03
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.01 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.01
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.01 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.01
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	Baseline	0.04 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.01
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.26 Fold change of % MAGE-A10+ CD8+ T cells	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.05 Fold change of % MAGE-A10+ CD8+ T cells	Standard Deviation 0.01

Primary

Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Ex vivo frequency of MAGE-A10-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at baseline.

Time frame: Fold change from baseline in MAGE-A10-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)

Arm	Measure	Group	Value (MEAN)	Dispersion
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.001 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.002
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.003
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.002
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.015 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.025
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	-0.001 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.02
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.127 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.154
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.003 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.006
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.034 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.079
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.043 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.076
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.002
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.027 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.044
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.016 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.051
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.005
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	-0.006 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.012
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.014 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.026
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.089 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	—
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.005
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.003 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.002
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	Standard Deviation 0.005
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.09 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.120 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T	—

Primary

Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Ex vivo frequency of Melan-A-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at baseline.

Time frame: Fold change from baseline in Melan-A-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: This test was only done in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)

Arm	Measure	Group	Value (MEAN)	Dispersion
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.010 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.025
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.001 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.002
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.003
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.027 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.06
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	-0.003 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.009
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.006 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.006
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.008 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.003
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.015 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.025
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.005 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.005
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.004 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.006
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.015 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.014
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.157 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.458
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.065 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.129
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.068 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.061
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.380 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.309
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.008 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.012
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.018 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.023
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.013 Fold change of % IFN-γ+ MelanA+ CD8+ T	Standard Deviation 0.011
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.051 Fold change of % IFN-γ+ MelanA+ CD8+ T	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	1.00 Fold change of % IFN-γ+ MelanA+ CD8+ T	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.150 Fold change of % IFN-γ+ MelanA+ CD8+ T	—

Primary

Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period

Ex vivo frequency of NY-ESO-1-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific CD8+ T cell frequency at the time point/ NY-ESO-1-specific CD8+ T cell frequency at baseline.

Time frame: Fold change from baseline in NY-ESO-1-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: This test was only done in patients HLA-A2 positive and NY-ESO-1 peptide positive (groups 2 and 3)

Arm	Measure	Group	Value (MEAN)	Dispersion
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.96 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 2.64
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 3	2.64 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 3.55
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	2.37 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 4.37
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Boost Cycles	1.40 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 2.4
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	Baseline	0.69 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 1.54
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.1 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 0.08
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	Baseline	0.01 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 0.02
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.21 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 0.28
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.19 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 0.23
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.16 Fold change of % NY-ESO-1+ CD8+ T cells	Standard Deviation 0.24

Primary

Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Ex vivo frequency of NY-ESO-1-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at baseline.

Time frame: Fold change from baseline in NY-ESO-1-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)

Arm	Measure	Group	Value (MEAN)	Dispersion
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	-0.001 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.002
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	-0.008 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.011
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.004 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.01
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.001 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.008
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.002 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.004
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.218 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.484
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.237 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.491
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	0.378 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.589
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	0.538 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.665
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.045 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.088
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Boost Cycles	0.096 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.121
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.002 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.065
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.001 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.001
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.004 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.006
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	-0.004 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.04
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.010 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.005
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 2	-0.003 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.009
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.001 % of spots from NYESO1 specific CD8 cell	Standard Deviation 0.005
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 3	-0.111 % of spots from NYESO1 specific CD8 cell	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	End of Cycle 1	0.030 % of spots from NYESO1 specific CD8 cell	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period	Baseline	0.050 % of spots from NYESO1 specific CD8 cell	—

Primary

Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period

Ex vivo frequency of Melan-A-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: Melan-A-specific CD8+ T cell frequency at the time point/ Melan-A-specific CD8+ T cell frequency at baseline. Significant T cell response is defined by at least 2-fold change of Melan-A-specific CD8+ T cell frequency as compared to pre-immunotherapy.

Time frame: Fold change from baseline in Melan-A-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months).

Population: This test was only performed in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)

Arm	Measure	Group	Value (MEAN)	Dispersion
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Baseline	0.03 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.03
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 3	0.10 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.07
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Boost Cycles	0.04 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.03
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 1	0.08 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.11
1.Melan-A ELA	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 2	0.07 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.06
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 3	0.08 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.07
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 2	0.14 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.12
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Boost Cycles	0.09 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.06
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 1	0.08 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.08
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Baseline	0.01 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.01
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Boost Cycles	2.66 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 2.72
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Baseline	0.08 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.15
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 1	0.37 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.33
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 2	0.34 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.31
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 3	0.85 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 1.36
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 3	0.09 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.09
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 1	0.12 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.16
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 2	0.20 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.22
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Baseline	0.18 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.29
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	Baseline	0.04 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.01
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 1	0.05 Fold change of % Melan-A ELA+ CD8+ T	Standard Deviation 0.01
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period	End of Cycle 2	0.26 Fold change of % Melan-A ELA+ CD8+ T	—

Primary

Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period

For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.

Time frame: Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Population: Patients vaccinated with the NY-ESO-1 lp (groups 4 and 5). One patient of the group 5 received only one vaccine and thus was not included in the analysis of the immune response (the minimum dose required for immune response evaluation was 2 vaccines).

Arm	Measure	Group	Value (MEAN)	Dispersion
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ at baseline	0.12 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 0.21
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ _end of cycle 1	2.86 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 4.94
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_ end of cycle 1	5.31 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 3.83
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells IFN-γ_end of cycle 2	1.81 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 3.26
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α _end of cycle 2	6.02 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 5.79
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells IFN-γ _end of cycle 3	7.02 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 14.01
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α _end of cycle 3	10.00 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 15.75
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T producing IFN-γ _end of boost cycles	19.47 % of NY-ESO-1 lp specific CD4+ T cells	—
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T producing TNF-α_end of boost cycles	21.11 % of NY-ESO-1 lp specific CD4+ T cells	—
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α at baseline	0.20 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 0.36
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ at baseline	071 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 1.3
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells IFN-γ_end of cycle 2	7.31 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 4.74
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α at baseline	1.05 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 1.65
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells IFN-γ _end of cycle 3	0.52 % of NY-ESO-1 lp specific CD4+ T cells	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ _end of cycle 1	16.24 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 9.73
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α _end of cycle 2	17.10 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 7.9
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_ end of cycle 1	23.69 % of NY-ESO-1 lp specific CD4+ T cells	Standard Deviation 12.22
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α _end of cycle 3	1.69 % of NY-ESO-1 lp specific CD4+ T cells	—

Primary

Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period

For each patient, total CD8+ T cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD8+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.

Time frame: Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD8+ T cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)

Arm	Measure	Group	Value (MEAN)	Dispersion
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ at baseline	0.03 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 0.08
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 1	0.88 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 1.96
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 1	1.04 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 2.08
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 2	0.34 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 0.46
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 2	2.18 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 3.48
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 3	0.93 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 1.81
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 3	1.01 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 1.74
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T producing IFN-γ_end of boost cycles	0.22 % of NY-ESO-1 lp specific CD8+ T cells	—
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T producing TNF-α_end of boost cycles	0.36 % of NY-ESO-1 lp specific CD8+ T cells	—
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α at baseline	0.02 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 0.04
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ at baseline	0.12 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 0.17
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 2	5.38 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 6.69
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α at baseline	0.15 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 0.26
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 3	6.58 % of NY-ESO-1 lp specific CD8+ T cells	—
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing IFN-γ_end of cycle 1	7.21 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 8.4
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 2	4.21 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 4.6
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 1	7.74 % of NY-ESO-1 lp specific CD8+ T cells	Standard Deviation 8.17
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period	NY-ESO-1lp T cells producing TNF-α_end of cycle 3	9.02 % of NY-ESO-1 lp specific CD8+ T cells	—

Secondary

Disease Status Assessment During the Vaccination Period

The disease status was assessed by computed tomography (CT) or positron emission tomography (PET)/CT at baseline and after the fourth vaccination of each cycle. During the booster vaccines period, imagery examinations were performed every 3 months for patients with measurable disease and every 6 months for patients with non measurable disease. The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as: * No Evidence of Disease (NED) * Stable disease (SD): Change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion. * Progressing disease (PD): Appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter.

Time frame: Disease status at baseline, after cycle 1 (3 months), after cycle 2 (8 months), after cycle 3 (13 months) and if applicable after boost cycles (16 months, 19 months or 22 months)

Population: Some patients discontinued treatment for either personal reasons or progressing disease. This is why from one cycle to other could be a decrease in the number of patients in the study.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	Baseline	Patients with No Evidence of Disease	7 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Progressing Disease	2 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with No Evidence of Disease	5 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Progressing Disease	2 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with No Evidence of Disease	1 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Progressing Disease	2 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Progressing Disease	1 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Stable Disease	0 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Stable Disease	1 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Stable Disease	1 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Stable Disease	0 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Stable Disease	0 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with No Evidence of Disease	7 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Progressing Disease	1 Participants
1.Melan-A ELA	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with No Evidence of Disease	7 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Progressing Disease	2 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	Baseline	Patients with No Evidence of Disease	2 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Stable Disease	0 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Progressing Disease	3 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Stable Disease	0 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with No Evidence of Disease	3 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with No Evidence of Disease	3 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Progressing Disease	0 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Progressing Disease	2 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with No Evidence of Disease	1 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Progressing Disease	1 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Stable Disease	0 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Stable Disease	0 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with No Evidence of Disease	3 Participants
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Stable Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Stable Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Progressing Disease	1 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with No Evidence of Disease	2 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Progressing Disease	2 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with No Evidence of Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Stable Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Progressing Disease	3 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with No Evidence of Disease	4 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Stable Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Progressing Disease	1 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with No Evidence of Disease	4 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Stable Disease	0 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Progressing Disease	1 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with No Evidence of Disease	3 Participants
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Progressing Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with No Evidence of Disease	5 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with No Evidence of Disease	6 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with No Evidence of Disease	4 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with No Evidence of Disease	1 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Progressing Disease	4 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Progressing Disease	2 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Stable Disease	0 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with No Evidence of Disease	7 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Progressing Disease	4 Participants
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Progressing Disease	3 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Progressing Disease	2 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Stable Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Stable Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with No Evidence of Disease	7 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with No Evidence of Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Stable Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 1	Patients with Stable Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with Progressing Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Progressing Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 3	Patients with No Evidence of Disease	2 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with No Evidence of Disease	2 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Cycle 2	Patients with Progressing Disease	3 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	Baseline	Patients with Stable Disease	0 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	Baseline	Patients with No Evidence of Disease	9 Participants
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2	Disease Status Assessment During the Vaccination Period	End of Boost Cycles	Patients with Progressing Disease	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Immunotherapy of Stage III/IV Melanoma Patients

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)

Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period

Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period

Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period

Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period

Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period

Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period

Disease Status Assessment During the Vaccination Period