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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.

IM solution, a course of 13 injections administered over 27 months

GSK 2132231A

Placebo

GSK Clinical Trials

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

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

GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

IPD is available via the Clinical Study Data Request site (click on the link provided below)

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).

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.

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).

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).

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.

The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.

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.

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.

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.

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.

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.

GlaxoSmithKline

MAGE-A3 Group

Placebo Group

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.

Total

Age, Continuous

Sex: Female, Male

Geographic ancestry

Race/Ethnicity, Customized

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.

GSK Response Center

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.

GS+ Mage-A3 Sub-Group

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.

GS+ Placebo Sub-Group

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.

GS- Mage-A3 Sub-Group

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.

GS- Placebo Sub-Group

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.

Disease Free Survival (DFS)

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.

OS, Final analysis

OS, Follow-up analysis

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.

Overall Survival (OS)

Disease-free Specific Survival (DFSS)

Distant Metastasis-free Survival (DMFS)

EQ-5D, Week 0 (day of TA)

EQ-5D, Week 0 (day after TA)

EQ-5D, Week 6 (day of TA)

EQ-5D, Week 6 (day after TA)

EQ-5D, Week 12 (day of TA)

EQ-5D, Week 12 (day after TA)

EQ-5D, Month 6

EQ-5D, Month 9

EQ-5D, Month 12

EQ-5D, Month 24

EQ-5D, Month 30 + 6 months

EQ-5D, Month 30 + 12 months

EQ-5D, Disease recurrence

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.

Health-related Quality of Life

Anti-MAGE-A3, Week 0

Anti-MAGE-A3, Week 6

Anti-MAGE-A3, Week 12

Anti-MAGE-A3, Week 36

Anti-MAGE-A3, Week 48

Anti-MAGE-A3, Week 72

Anti-MAGE-A3, Week 120

Anti-MAGE-A3, Week 120+6 months

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.

Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value

Anti-MAGE-A3 Antibody Geometric Mean Concentrations

Number of Subjects With Anti-MAGE-A3 Antibody Response

ALT, Unknown - G0

ALT, Unknown - G1

ALT, Unknown - G2

ALT, Unknown - G3

ALT, Unknown - G4

ALT, Unknown - Unknown

ALT, G0 - G0

ALT, G0 - G1

ALT, G0 - G2

ALT, G0 - G3

ALT, G0 - G4

ALT, G0 - Unknown

ALT, G1 - G0

ALT, G1 - G1

ALT, G1 - G2

ALT, G1 - G3

ALT, G1 - G4

ALT, G1 - Unknown

ALT, G2 - G0

ALT, G2 - G1

ALT, G2 - G2

ALT, G2 - G3

ALT, G2 - G4

ALT, G2 - Unknown

ALT, G3 - G0

ALT, G3 - G1

ALT, G3 - G2

ALT, G3 - G3

ALT, G3 - G4

ALT, G3 - Unknown

ALT, Total - G0

ALT, Total - G1

ALT, Total - G2

ALT, Total - G3

ALT, Total - G4

ALT, Total - Unknown

AST, Unknown - G0

AST, Unknown - G1

AST, Unknown - G2

AST, Unknown - G3

AST, Unknown - G4

AST, Unknown - Unknown

AST, G0 - G0

AST, G0 - G1

AST, G0 - G2

AST, G0 - G3

AST, G0 - G4

AST, G0 - Unknown

AST, G1 - G0

AST, G1 - G1

AST, G1 - G2

AST, G1 - G3

AST, G1 - G4

AST, G1 - Unknown

AST, G2 - G0

AST, G2 - G1

AST, G2 - G2

AST, G2 - G3

AST, G2 - G4

AST, G2 - Unknown

AST, Total - G0

AST, Total - G1

AST, Total - G2

AST, Total - G3

AST, Total - G4

AST, Total - Unknown

AP, Unknown - G0

AP, Unknown - G1

AP, Unknown - G2

AP, Unknown - G3

AP, Unknown - G4

AP, Unknown - Unknown

AP, G0 - G0

AP, G0 - G1

AP, G0 - G2

AP, G0 - G3

AP, G0 - G4

AP, G0 - Unknown

AP, G1 - G0

AP, G1 - G1

AP, G1 - G2

AP, G1 - G3

AP, G1 - G4

AP, G1 - Unknown

AP, Total - G0

AP, Total - G1

AP, Total - G2

AP, Total - G3

AP, Total - G4

AP, Total - Unknown

BIL, Unknown - G0

BIL, Unknown - G1

BIL, Unknown - G2

BIL, Unknown - G3

BIL, Unknown - G4

BIL, Unknown - Unknown

BIL, G0 - G0

BIL, G0 - G1

BIL, G0 - G2

BIL, G0 - G3

The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.

Number of Subjects With Abnormal Haematological and Biochemical Parameters

Number of Subjects With Any Adverse Events (AEs)

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