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Clinical Trial Results:
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III).

Summary
EudraCT number	2006-004777-10
Trial protocol	GB BE DE FR IT
Global end of trial date	08 Aug 2013

Results information
Results version number	v2(current)
This version publication date	13 Aug 2016
First version publication date	13 Jun 2015
Other versions	v1
Version creation reason	Correction of full data set Data (typos) were corrected.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

107240

ISRCTN number

US NCT number

NCT00455572

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Jun 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Aug 2013

Global end of trial reached?

Yes

Global end of trial date

08 Aug 2013

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the humoral and cellular immune response induced by recMAGE-A3+AS15 in patients with MAGE-A3-positive Non-Small Cell Lung Cancer (NSCLC). • To evaluate the safety of recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC.

Protection of trial subjects

All subjects were supervised after MAGE-A3 ASCI study product administration with appropriate medical treatment readily available. The MAGE-A3 ASCI study product was administered by qualified and trained personnel, and only to eligible patients who had no contraindications to any components of the MAGE-A3 ASCI study product. Subjects were followed up for occurrences of adverse events (AEs), including abnormal hematological and biochemical laboratory values, potential immune-mediated disorders (pIMDs and serious adverse events (SAEs) during the entire study period study. For subjects in all groups, if during the study the investigator was to come to consider any deviation from protocol-defined rules as to be in the patient's interest, then the investigator's decision was given priority over the rules. For Cohort 4, the chemo- and radiotherapy regimen was based upon the site's own standard procedures; again, the choice of treatment and any modification of this was to be governed by considerations of the patient's interest. Chemo- and radiotherapy may be administered in either sequence or concurrently. All patients who withdrew from the study and who had received any dose of study treatment were encouraged to be followed for assessment of possible toxicity. These patients were to be examined not less than 30 days and not more than 37 days after the last administration of MAGE-A3 ASCI study product.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 May 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 8

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

France: 18

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

Italy: 11

Country: Number of subjects enrolled

Canada: 3

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

70 patients were screened towards participation in the study. Out of these 70 patients, 67 were assessed as eligible for treatment and were administered the study MAGE-A3 ASCI study treatment.

Period 1 title

Overall Study Period (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Chemotherapy + MAGE-A3 ASCI Group

Arm description

This group (Cohort 1 as per protocol summary) consisted in patients aged 18 years or more with completely resected stage IB, II or III tumors, who are due for chemotherapy, who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product concurrently with cis-diaminedichloroplatine (CDDP) + vinorelbine [either Vinorelbine or Pierre Fabre’s Navelbine] chemotherapy. The 8-dose course of MAGE-A3 ASCI study product was administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to receive up to 4 cycles of chemotherapy at 3-week intervals: 1 standard dose of CDDP and of vinorelbine intravenously on the first day of each cycle (starting at Week -1) and 1 standard dose of vinorelbine intravenously on Day 8 of each cycle, concomitantly with MAGE-A3 ASCI administration.

Arm type

Experimental

Investigational medicinal product name

recMAGE-A3 recombinant protein formulated in AS15 adjuvant

Investigational medicinal product code

recMAGE-A3 + AS15

Other name

GSK1572932A; MAGE-A3 ASCI

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Patients received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product. The 8-dose course of MAGE-A3 ASCI study product was to be administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area.

Chemotherapy/MAGE-A3 ASCI Group

Arm description

This group (Cohort 2 as per protocol summary) consisted in patients aged 18 years or more with completely resected stage IB, II or III tumors who are due for chemotherapy, who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product after receiving cis-diaminedichloroplatine (CDDP) + vinorelbine [either Vinorelbine or Pierre Fabre’s Navelbine chemotherapy. The 8-dose course of MAGE-A3 ASCI was administered according to a 3-week intervals schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to received at least 2 cycles of chemotherapy ,(1 standard dose of CDDP and of vinorelbine intravenously on the first day of each cycle and 1 dose of vinorelbine on Day 8 of each cycle), the last dose received to 4 weeks prior Dose 1 of MAGE-A3 ASCI. No additional chemotherapy was administered to patients from Week 0 onwards.

Arm type

Experimental

Investigational medicinal product name

recMAGE-A3 recombinant protein formulated in AS15 adjuvant

Investigational medicinal product code

recMAGE-A3 + AS15

Other name

GSK1572932A; MAGE-A3 ASCI

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

MAGE-A3 ASCI Group

Arm description

This group (Cohort 3 as per protocol summary) consisted in patients aged 18 years or more with completely resected stage IB, II or III tumors who are not due for cis-diaminedichloroplatine (CDDP) + vinorelbine chemotherapy, who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product. The 8-dose course of MAGE-A3 ASCI study product was administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to have had their tumor resected at least 4 to 8 weeks prior to receiving Dose 1 of MAGE-A3 ASCI product and to receive no chemo-/radiotherapy during the entire duration of the study.

Arm type

Experimental

Investigational medicinal product name

recMAGE-A3 recombinant protein formulated in AS15 adjuvant

Investigational medicinal product code

recMAGE-A3 + AS15

Other name

GSK1572932A; MAGE-A3 ASCI

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Chemo/radiotherapy-MAGE-A3 ASCI Group

Arm description

This group (Cohort 4 as per protocol summary) consisted in patients aged 18 years or more with unresectable stage III tumors following chemotherapy and radiotherapy who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product. The 8-dose course of MAGE-A3 ASCI study product was to be administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to have received their last dose of chemotherapy (cis-diaminedichloroplatine [CDDP] + vinorelbine [either the generic Vinorelbine or Pierre Fabre’s Navelbine]) and/or radiotherapy 2 to 6 weeks prior to receiving Dose 1 of MAGE-A3 ASCI product. No additional chemo-/radiotherapy was administered to patients in this cohort from Week 0 onwards.

Arm type

Experimental

Investigational medicinal product name

recMAGE-A3 recombinant protein formulated in AS15 adjuvant

Investigational medicinal product code

recMAGE-A3 + AS15

Other name

GSK1572932A; MAGE-A3 ASCI

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Number of subjects in period 1 ^[1]	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Started	19	18	18	12
Completed	15	14	8	8
Not completed	4	4	10	4
Adverse event, serious fatal	-	-	-	1
Adverse event, non-fatal	1	-	2	-
Recurrence/Disease Progression	-	4	6	3
Second cancer, reduced compliance and comorbidity	3	-	-	-
Other reasons	-	-	2	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 70 patients were screened towards participation in the study. Out of these 70 patients, 67 were assessed as eligible for treatment and were administered the study MAGE-A3 ASCI study treatment.

Baseline characteristics

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Reporting group title

Chemotherapy + MAGE-A3 ASCI Group

Reporting group description

Reporting group title

Chemotherapy/MAGE-A3 ASCI Group

Reporting group description

Reporting group title

MAGE-A3 ASCI Group

Reporting group description

Reporting group title

Chemo/radiotherapy-MAGE-A3 ASCI Group

Reporting group description

Reporting group values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group	Total
Number of subjects	19	18	18	12	67
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: years
arithmetic mean (standard deviation)	58.7 ( 10.3 )	60.6 ( 6.37 )	67.1 ( 9.81 )	59.9 ( 7.33 )	-
Gender categorical
Units: Subjects
Female	14	15	16	7	52
Male	5	3	2	5	15

End points

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Reporting group title

Chemotherapy + MAGE-A3 ASCI Group

Reporting group description

Reporting group title

Chemotherapy/MAGE-A3 ASCI Group

Reporting group description

Reporting group title

MAGE-A3 ASCI Group

Reporting group description

Reporting group title

Chemo/radiotherapy-MAGE-A3 ASCI Group

Reporting group description

Primary: Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

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End point title

Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies ^[1]

End point description

A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies ≥ the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). The W6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The Study End (SE) time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the Study Early Termination (ET) time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Screening (SCR), At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early Termination (ET)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	16	12
Units: Subjects
Anti-MAGE-A3, SCR (N=19;18;16;12)	1	4	0	1
Anti-MAGE-A3, W6 (N= 13;0;0;0)	12	0	0	0
Anti-MAGE-A3, W7 (N=11;15;13;10)	11	14	13	9
Anti-MAGE-A3, W13 (N=12;15;12;9)	12	15	12	9
Anti-MAGE-A3, W16 (N=12;16;10;8)	12	16	10	8
Anti-MAGE-A3, W19 (N=13;14;11;8)	13	14	11	8
Anti-MAGE-A3, W22 (N=15;12;8;8)	15	12	8	8
Anti-MAGE-A3, W27 (N=15;13;9;7)	15	13	9	7
Anti-MAGE-A3, SE (N=2;4;4;0)	1	4	4	0
Anti-MAGE-A3, ET (N=0;0;0;2)	0	0	0	2

No statistical analyses for this end point

Primary: Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies

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End point title

Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies ^[2]

End point description

A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies ≥/< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration ≥ 27 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.. The Week 6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early termination (ET)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	15	16	12	10
Units: Subjects
Anti-MAGE-A3, W6 (N=13;0;0;0)	12	0	0	0
Anti-MAGE-A3, W7 (N=11;15;12;10)	11	14	12	9
Anti-MAGE-A3, W13 (N=12;15;10;9)	12	15	10	9
Anti-MAGE-A3, W16 (N=12;16;8;8)	12	16	8	8
Anti-MAGE-A3, W19 (N=13;14;9;8)	13	14	9	8
Anti-MAGE-A3, W22 (N=15;12;8;8)	15	12	8	8
Anti-MAGE-A3, W27 (N=15;13;8;7)	15	13	8	7
Anti-MAGE-A3, SE (N=2;4;3;0)	1	4	3	0
Anti-MAGE-A3, ET (N=0;0;0;2)	0	0	0	2

No statistical analyses for this end point

Primary: Concentrations for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

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End point title

Concentrations for anti-Melanoma AntiGEn (MAGE)-A3 antibodies ^[3]

End point description

The seropositivity cut-off of the assay was ≥ 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). The Week 6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Screening (SCR), At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early termination (ET)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	16	12
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-MAGE-A3, SCR (N=19;18;16;12)	11 (9.5 to 12.8)	13.9 (10 to 19.2)	10.6 (9.3 to 12.1)	11.8 (9.2 to 15.1)
Anti-MAGE-A3, W6 (N= 13;0;0;0)	330.5 (93.8 to 1164.1)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-MAGE-A3, W7 (N=11;15;13;10)	438.8 (138.2 to 1393.9)	1171.1 (413.5 to 3316.6)	698 (370.2 to 1316)	975.3 (151.3 to 6288.8)
Anti-MAGE-A3, W13 (N=12;15;12;9)	1711.7 (804 to 3644.6)	4336.1 (2971.4 to 6327.6)	3051.3 (1808.9 to 5147.2)	4927.5 (1147.8 to 21152.5)
Anti-MAGE-A3, W16 (N=12;16;10;8)	4250.4 (2244.4 to 8049.4)	5433.6 (3704.4 to 7969.8)	4360.1 (2484 to 7653.2)	5219 (1189.5 to 22898)
Anti-MAGE-A3, W19 (N=13;14;11;8)	4828.8 (2955.6 to 7889.1)	5217.6 (3888.8 to 7000.4)	4298.1 (2802.1 to 6592.7)	5557.9 (1138 to 27143.6)
Anti-MAGE-A3, W22 (N=15;12;8;8)	4097.8 (2645.3 to 6347.8)	4442.7 (3041.7 to 6489.1)	4447.5 (2381.3 to 8306.4)	8301.9 (5111 to 13484.9)
Anti-MAGE-A3, W27 (N=15;13;9;7)	3591.2 (2199.9 to 5862.4)	4339.9 (3305.4 to 5698.1)	4213.4 (2386.1 to 7440.3)	6406.5 (3594.9 to 11417.1)
Anti-MAGE-A3, SE (N=2;4;4;0)	16.7 (0 to 11599)	3155.1 (1306 to 7622.2)	2974.1 (429.5 to 20592.2)	0 (0 to 0)
Anti-MAGE-A3, ET (N=0;0;0;2)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	865.2 (227.9 to 3284.3)

No statistical analyses for this end point

Primary: Number of subjects seropositive for anti-protein D (PD) antibodies

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End point title

Number of subjects seropositive for anti-protein D (PD) antibodies ^[4]

End point description

A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies ≥ the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). The Week 6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Screening (SCR), At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early termination (ET)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	17	17	12
Units: Subjects
Anti-PD, SCR (N=19;17;17;12)	3	4	6	1
Anti-PD, W6 (N=14;0;0;0)	14	0	0	0
Anti-PD, W7 (N=12;17;14;11)	12	16	14	11
Anti-PD, W13 (N=15;15;12;9)	15	15	12	9
Anti-PD, W16 (N=15;16;11;8)	15	16	11	8
Anti-PD, W19 (N=15;14;11;8)	15	14	11	8
Anti-PD, W22 (N=15;12;9;8)	15	12	9	8
Anti-PD, W27 (N=15;13;9;7)	15	13	9	7
Anti-PD, SE (N=2;4;4;0)	1	4	4	0
Anti-PD, ET (N=0;0;0;2)	0	0	0	2

No statistical analyses for this end point

Primary: Number of humoral responders as regards anti-protein D (PD) antibodies

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End point title

Number of humoral responders as regards anti-protein D (PD) antibodies ^[5]

End point description

A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. The Week 6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early termination (ET)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	15	16	13	11
Units: Subjects
Anti-PD, W6 (N=14;0;0;0)	14	0	0	0
Anti-PD, W7 (N=12;16;13;11)	12	15	13	11
Anti-PD, W13 (N=15;14;11;9)	15	14	11	9
Anti-PD, W16 (N=15;15;10;8)	15	15	10	8
Anti-PD, W19 (N=15;13;10;7)	15	13	10	7
Anti-PD, W22 (N=15;11;9;8)	15	11	9	8
Anti-PD, W27 (N=15;12;9;7)	15	12	9	7
Anti-PD, SE (N=2;4;3;0)	1	4	3	0
Anti-PD, ET (N=0;0;0;2)	0	0	0	2

No statistical analyses for this end point

Primary: Concentrations for anti-protein D (PD) antibodies

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End point title

Concentrations for anti-protein D (PD) antibodies ^[6]

End point description

The seropositivity cut-off of the assay was ≥ 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). The Week 6 time point was only applicable to Chemotherapy + MAGE-A3 Group. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Screening (SCR), At Weeks 6, 7, 13, 16, 19, 22 and 27 (W6, W7, W13, W16, W19, W22 and W27) and at Study End (SE) or Study Early termination (ET)

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	17	17	12
Units: EL.U/mL
geometric mean (confidence interval 95%)
Anti-PD, SCR (N=19;17;17;12)	65.9 (47.7 to 91.1)	68.2 (49.5 to 94.1)	95.5 (51.2 to 177.9)	53.4 (46.2 to 61.7)
Anti-PD, W6 (N=14;0;0;0)	5126.7 (2628.8 to 9998)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Anti-PD, W7 (N=12;17;14;11)	5876.6 (2883.1 to 11978.4)	5871.1 (2309.1 to 14928.1)	6602.4 (2562.9 to 17008.8)	5393 (1649.1 to 17635.9)
Anti-PD, W13 (N=15;15;12;9)	12842.6 (8672.1 to 19018.6)	16939.9 (9795.5 to 29295.4)	16165.9 (7282.9 to 35883.6)	13156.1 (6284.7 to 27540.5)
Anti-PD, W16 (N=15;16;11;8)	17930.8 (12187.9 to 26379.8)	18029.7 (10977.9 to 29611.4)	22195.2 (9535.6 to 51662.1)	13226.5 (8515.5 to 20543.7)
Anti-PD, W19 (N=15;14;11;8)	19471.8 (12865.4 to 29470.6)	17596.2 (11081.5 to 27940.7)	23456 (11664.4 to 47168)	15897.8 (9817.5 to 25743.7)
Anti-PD, W22 (N=15;12;9;8)	19050.7 (12332.1 to 29429.6)	18349.4 (10737.7 to 31356.7)	27568.7 (10652.2 to 71349.7)	16729.1 (10358 to 27018.9)
Anti-PD, W27 (N=15;13;9;7)	16698.6 (10475 to 26619.7)	14190.5 (9343.3 to 21552.4)	27919.6 (13083.6 to 59578.7)	13906.9 (8197.6 to 23592.3)
Anti-PD, SE (N=2;4;4;0)	231.8 (0 to 67660000)	10620.8 (7991.3 to 14115.6)	11438.9 (2879.3 to 45444.1)	0 (0 to 0)
Anti-PD, ET (N=0;0;0;2)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	8836.1 (0 to 28094000)

No statistical analyses for this end point

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

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End point title

Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity ^[7]

End point description

A patient seropositive as regards MAGE-A3 CD4 T-cell immunogenicity was defined as a patient with geometric mean ratios (GMRs) between stimulated and unstimulated PBMC in a multiwell assay for the percentage of interferon (IFN)- and tumor necrosis factor (TNF)- double positive CD4 T-cells responding to MAGE-A3 overlapping peptide stimulation (IFN-g+TNF-aDble+ CD4) ≥ the 8.4% seropositivity cut-off. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At screening (SCR), at Weeks 13 and 27 (W13 and W27), and at Study End (SE) or Study Early termination (ET)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	14	17	11	8
Units: Subjects
IFN-g+TNF-aDble+ CD4, SCR (N=13;17;11;8)	3	1	0	1
IFN-g+TNF-aDble+ CD4, W13 (N=12;13;8;8)	7	4	2	5
IFN-g+TNF-aDble+ CD4, W27 (N=14;13;6;7)	9	4	4	6
IFN-g+TNF-aDble+ CD4, SE (N=2;1;1;0)	0	0	0	0
IFN-g+TNF-aDble+ CD4, ET (N=0;0;0;2)	0	0	0	1

No statistical analyses for this end point

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

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End point title

Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity ^[8]

End point description

A patient seropositive/seronegative for MAGE-A3 Cluster of Differentiation (CD)4 T-cell was a patient with geometric mean ratios (GMRs) for the percentage of IFN- and TNF- double positive CD4 T-cells responding to MAGE-A3 peptide stimulation (IFN-g+TNF-aDble+ CD4) ≥ /< the 8.4% cut-off. A patient responder as MAGE-A3 CD4 T-cell was defined as follows: 1/for initially seronegative patients: post-administration antibody titer ≥ 8.4% for IFN-g+TNF-aDble+ CD4, or 2/for initially seropositive patients: post-administration antibody titer ≥ 4 fold the pre-vaccination antibody titer. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group. Please note that overlap was reported for W13 and W17, for 3 and 2 patients in the Chemotherapy + MAGE-A3 ASCI and Chemotherapy/MAGE-A3 ASCI groups, respectively, for whom a cellular response was found.

End point type

Primary

End point timeframe

At Weeks 13 and 27 (W13 and W27), and at Study End (SE) or Study Early termination (ET)

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	9	13	6	4
Units: Subjects
IFN-g+TNF-aDble+ CD4, W13 (N=7;12;6;4)	4	3	0	2
IFN-g+TNF-aDble+ CD4, W27 (N=9;13;4;4)	3	3	2	4
IFN-g+TNF-aDble+ CD4, SE (N=2;1;1;0)	0	0	0	0
IFN-g+TNF-aDble+ CD4, ET (N=0;0;0;2)	0	0	0	1

No statistical analyses for this end point

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

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End point title

Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity ^[9]

End point description

A patient seropositive as regards MAGE-A3 CD8 T-cell immunogenicity was defined as a patient with geometric mean ratios (GMRs) between stimulated and unstimulated PBMC in a multiwell assay for the percentage of IFN- and TNF- double positive CD8 T-cells responding to MAGE-A3 overlapping peptide stimulation (IFN-g+TNF-aDble+ CD8) ≥ the 3.2% seropositivity cut-off. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At screening (SCR), at Weeks 13 and 27 (W13 and W27), and at Study End (SE) or Study Early termination (ET)

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	14	17	11	8
Units: Subjects
IFN-g+TNF-aDble+ CD8, SCR (N=13;17;11;8)	0	2	0	0
IFN-g+TNF-aDble+ CD8, W13 (N=12;13;8;8)	2	1	2	1
IFN-g+TNF-aDble+ CD8, W27 (N=14;13;6;7)	1	3	0	1
IFN-g+TNF-aDble+ CD8, SE (N=2;1;1;0)	1	0	0	0
IFN-g+TNF-aDble+ CD8, ET (N=0;0;0;2)	0	0	0	0

No statistical analyses for this end point

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

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End point title

Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity ^[10]

End point description

A patient seropositive/seronegative for MAGE-A3 Cluster of Differentiation (CD)8 T-cell was a patient with geometric mean ratios (GMRs) for the percentage of IFN- and TNF- double positive CD8 T-cells responding to MAGE-A3 peptide stimulation (IFN-g+TNF-aDble+ CD8) ≥ /< the 3.2% cut-off. A patient responder as MAGE-A3 CD8 T-cell was defined as follows: 1/for initially seronegative patients: post-administration antibody titer ≥ 3.2% for IFN-g+TNF-aDble+ CD8, or 2/for initially seropositive patients: post-administration antibody titer ≥ 4 fold the pre-vaccination antibody titer. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

At Weeks 13 and 27 (W13 and W27), and at Study End (SE) or Study Early termination (ET)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	9	13	6	4
Units: Subjects
IFN-g+TNF-aDble+ CD8, W13 (N=7;12;6;4)	1	0	0	1
IFN-g+TNF-aDble+ CD8, W27 (N=9;13;4;4)	0	1	0	1
IFN-g+TNF-aDble+ CD8, SE (N=2;1;1;0)	0	0	0	0
IFN-g+TNF-aDble+ CD8, ET (N=0;0;0;2)	0	0	0	0

No statistical analyses for this end point

Primary: Number of patients with abnormal haemoglobin laboratory values by maximum grade

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End point title

Number of patients with abnormal haemoglobin laboratory values by maximum grade ^[11]

End point description

The status of each patient as regards haemoglobin (HAE) laboratory values at baseline and from screening up to Study End (SE) (Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups) or Study Early termination (ET) (Chemo/radiotherapy-MAGE-A3 ASCI Group) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. By screening status, it was assessed whether the post-treatment values were above, below or in the normal range. Screening CTC grade statuses were Grade 0 (G0) and G1. Overall study post-treatment (PT) CTC grade statuses were, G0, G1, G2, G3, G4, G5 and Unknown (UNK).

End point type

Primary

End point timeframe

At screening (SCR) and throughout the entire study duration, from SCR to Study End (SE) or Study Early termination (ET)

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
HAE - SCR G0; PT G1	7	1	1	0
HAE - SCR G0; PT G2	0	0	0	0
HAE - SCR G0; PT G3	0	0	0	0
HAE - SCR G0; PT G4	0	0	0	0
HAE - SCR G0; PT G5	0	0	0	0
HAE - SCR G0; PT UNK	0	0	4	2
HAE - SCR G1; PT G1	5	8	5	2
HAE - SCR G1; PT G2	2	0	0	0
HAE - SCR G1; PT G3	0	0	0	0
HAE - SCR G1; PT G4	0	0	0	0
HAE - SCR G1; PT G5	0	0	0	0
HAE - SCR G1; PT UNK	1	1	1	2

No statistical analyses for this end point

Primary: Number of patients with abnormal leukocytes laboratory values by maximum grade

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End point title

Number of patients with abnormal leukocytes laboratory values by maximum grade ^[12]

End point description

The status of each patient as regards leukocytes (LEU) laboratory values at baseline and from screening up to Study End (SE) (Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups) or Study Early termination (ET) (Chemo/radiotherapy-MAGE-A3 ASCI Group) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. By screening status, it was assessed whether the post-treatment values were above, below or in the normal range. Screening CTC grade statuses were Grade 0 (G0) and G1. Overall study post-treatment (PT) CTC grade statuses were, G0, G1, G2, G3, G4, G5 and Unknown (UNK).

End point type

Primary

End point timeframe

At screening (SCR) and throughout the entire study duration, from SCR to Study End (SE) or Study Early termination (ET)

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
LEU - SCR G0; PT G1	0	2	1	0
LEU - SCR G0; PT G2	0	0	0	0
LEU - SCR G0; PT G3	0	0	0	0
LEU - SCR G0; PT G4	0	0	0	0
LEU - SCR G0; PT G5	0	0	0	0
LEU - SCR G0; PT UNK	1	1	5	4
LEU - SCR G1; PT G1	0	0	0	2
LEU - SCR G1; PT G2	0	0	0	0
LEU - SCR G1; PT G3	0	0	0	0
LEU - SCR G1; PT G4	0	0	0	0
LEU - SCR G1; PT G5	0	0	0	0
LEU - SCR G1; PT UNK	0	0	0	0

No statistical analyses for this end point

Primary: Number of patients with abnormal lymphopenia laboratory values by maximum grade

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End point title

Number of patients with abnormal lymphopenia laboratory values by maximum grade ^[13]

End point description

The status of each patient as regards lymphopenia (LYM) laboratory values at baseline and from screening up to Study End (SE) (Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups) or Study Early termination (ET) (Chemo/radiotherapy-MAGE-A3 ASCI Group) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. By screening status, it was assessed whether the post-treatment values were above, below or in the normal range. Screening CTC grade statuses were Unknown (UNK), Grade 0 (G0), G1, G2, G3. Overall study post-treatment (PT) CTC grade statuses were, G0, G1, G2, G3, G4, G5 and Unknown (UNK).

End point type

Primary

End point timeframe

At screening (SCR) and throughout the entire study duration, from SCR to Study End (SE) or Study Early termination (ET)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
LYM - SCR UNK; PT G1	0	0	0	1
LYM - SCR UNK; PT G2	0	0	0	0
LYM - SCR UNK; PT G3	0	0	0	0
LYM - SCR UNK; PT G4	0	0	0	0
LYM - SCR UNK; PT G5	0	0	0	0
LYM - SCR UNK; PT UNK	0	0	0	0
LYM - SCR G0; PT G1	1	0	2	1
LYM - SCR G0; PT G2	0	0	0	0
LYM - SCR G0; PT G3	0	0	0	0
LYM - SCR G0; PT G4	0	0	0	0
LYM - SCR G0; PT G5	0	0	0	0
LYM - SCR G0; PT UNK	1	1	4	0
LYM - SCR G1; PT G1	0	1	0	0
LYM - SCR G1; PT G2	0	0	0	0
LYM - SCR G1; PT G3	0	0	0	0
LYM - SCR G1; PT G4	0	0	0	0
LYM - SCR G1; PT G5	0	0	0	0
LYM - SCR G1; PT UNK	0	0	1	1
LYM - SCR G2; PT G1	0	0	0	1
LYM - SCR G2; PT G2	0	1	1	1
LYM - SCR G2; PT G3	0	0	0	0
LYM - SCR G2; PT G4	0	0	0	0
LYM - SCR G2; PT G5	0	0	0	0
LYM - SCR G2; PT UNK	0	0	0	3
LYM - SCR G3; PT G1	0	0	0	1
LYM - SCR G3; PT G2	0	0	0	2
LYM - SCR G3; PT G3	0	0	1	0
LYM - SCR G3; PT G4	0	0	0	0
LYM - SCR G3; PT G5	0	0	0	0
LYM - SCR G3; PT UNK	0	0	0	0

No statistical analyses for this end point

Primary: Number of patients with abnormal neutrophils laboratory values by maximum grade

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End point title

Number of patients with abnormal neutrophils laboratory values by maximum grade ^[14]

End point description

The status of each patient as regards neutrophils (NEU) laboratory values at baseline and from screening up to Study End (SE) (Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups) or Study Early termination (ET) (Chemo/radiotherapy-MAGE-A3 ASCI Group) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. By screening status, it was assessed whether the post-treatment values were above, below or in the normal range. Screening CTC grade statuses were Grade 0 (G0) and G1. Overall study post-treatment (PT) CTC grade statuses were, G0, G1, G2, G3, G4, G5 and Unknown (UNK).

End point type

Primary

End point timeframe

At screening (SCR) and throughout the entire study duration, from SCR to Study End (SE) or Study Early termination (ET)

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
NEU - SCR G0; PT G1	0	0	1	1
NEU - SCR G0; PT G2	0	0	0	0
NEU - SCR G0; PT G3	0	0	0	0
NEU - SCR G0; PT G4	0	0	0	0
NEU - SCR G0; PT G5	0	0	0	0
NEU - SCR G0; PT UNK	1	0	5	4
NEU - SCR G1; PT G1	0	0	0	0
NEU - SCR G1; PT G2	0	0	0	0
NEU - SCR G1; PT G3	0	0	0	0
NEU - SCR G1; PT G4	0	0	0	0
NEU - SCR G1; PT G5	0	0	0	0
NEU - SCR G1; PT UNK	0	1	0	0

No statistical analyses for this end point

Primary: Number of patients with abnormal platelets laboratory values by maximum grade

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End point title

Number of patients with abnormal platelets laboratory values by maximum grade ^[15]

End point description

The status of each patient as regards platelets (PLA) laboratory values at baseline and from screening up to Study End (SE) (Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups) or Study Early termination (ET) (Chemo/radiotherapy-MAGE-A3 ASCI Group) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. By screening status, it was assessed whether the post-treatment values were above, below or in the normal range. Screening CTC grade statuses were Grade 0 (G0) and G1. Overall study post-treatment (PT) CTC grade statuses were, G0, G1, G2, G3, G4, G5 and Unknown (UNK).

End point type

Primary

End point timeframe

At screening (SCR) and throughout the entire study duration, from SCR to Study End (SE) or Study Early termination (ET)

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
PLA - SCR G0; PT G1	0	1	0	0
PLA - SCR G0; PT G2	0	0	0	0
PLA - SCR G0; PT G3	0	0	0	0
PLA - SCR G0; PT G4	0	0	0	0
PLA - SCR G0; PT G5	0	0	0	0
PLA - SCR G0; PT UNK	1	1	5	3
PLA - SCR G1; PT G1	0	0	1	1
PLA - SCR G1; PT G2	0	0	0	0
PLA - SCR G1; PT G3	0	0	0	0
PLA - SCR G1; PT G4	0	0	0	0
PLA - SCR G1; PT G5	0	0	0	0
PLA - SCR G1; PT UNK	0	1	0	1

No statistical analyses for this end point

Primary: Number of patients with adverse events (AEs) by maximum grade

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End point title

Number of patients with adverse events (AEs) by maximum grade ^[16]

End point description

An AE was defined any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Patients’ statuses as regards AEs reported from screening up to SE/ET was collected and graded according to the Common Terminology Criteria (CTC) AE terminology, version 3.0. The maximum grades reported were compiled. Grades compiled were Grade (G) 0, G1, G2, G3 and G4 for all groups as well as G5 for the Chemo/radiotherapy-MAGE-A3 ASCI Group only. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

Throughout the entire study duration, from screening (SCR) to Study End (SE) or Study Early termination (ET)

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
G1 AEs maximum	0	8	1	5
G2 AEs maximum	3	8	11	5
G3 AEs maximum	5	2	3	1
G4 AEs maximum	11	0	2	0
G5 AEs maximum	0	0	0	1

No statistical analyses for this end point

Primary: Number of patients with potential immune-mediated diseases (pIMDs)

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End point title

Number of patients with potential immune-mediated diseases (pIMDs) ^[17]

End point description

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET time point is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

Throughout the entire study duration, from screening (SCR) to Study End (SE) or Study Early termination (ET)

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
pIMD(s)	1	0	0	0

No statistical analyses for this end point

Primary: Number of patients with unsolicited adverse events (AEs), irrespective of grade

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End point title

Number of patients with unsolicited adverse events (AEs), irrespective of grade ^[18]

End point description

An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

End point type

Primary

End point timeframe

Within the 31-day follow-up period post study product administration.

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
Any AE	19	18	17	11

No statistical analyses for this end point

Primary: Number of patients with serious adverse events (SAEs)

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End point title

Number of patients with serious adverse events (SAEs) ^[19]

End point description

A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to the Common Terminology Criteria for Adverse Events, Version 3.0. Progression of disease or cancer recurrence were not reported as a SAE. However, if the progression of the underlying disease was greater than that which would normally be expected for the patient. If a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence was assessed, the event was reported as SAE. Any new cancer (not related to the cancer under study) was reported as a SAE. The SE time point is only applicable to the Chemotherapy + MAGE-A3, Chemotherapy/MAGE-A3 ASCI and MAGE-A3 ASCI groups and the ET is only applicable to the Chemo/radiotherapy-MAGE-A3 ASCI Group.

End point type

Primary

End point timeframe

Throughout the entire study duration, from screening (SCR) to Study End (SE) or Study Early termination (ET)

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Chemotherapy + MAGE-A3 ASCI Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Number of subjects analysed	19	18	18	12
Units: Subjects
Any SAE	12	0	4	3

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

SAEs: From screening to study end/early termination; Unsolicited AEs: Within the 31-day follow-up period post study product administration.

Adverse event reporting additional description

The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

Chemotherapy + MAGE-A3 Group

Reporting group description

This group (Cohort 1 as per protocol summary) consisted in patients aged 18 years or more with completely resected stage IB, II or III tumors, who are due for chemotherapy, who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product concurrently with cis-diaminedichloroplatine (CDDP) + vinorelbine [either Vinorelbine®or Pierre Fabre’s Navelbine®] chemotherapy. The 8-dose course of MAGE-A3 ASCI study product was administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to receive up to 4 cycles of chemotherapy at 3-week intervals: 1 standard dose of CDDP and of vinorelbine intravenously on the first day of each cycle (starting at Week -1) and 1 standard dose of vinorelbine intravenously on Day 8 of each cycle, concomitantly with MAGE-A3 ASCI administration.

Reporting group title

Chemotherapy/MAGE-A3 ASCI Group

Reporting group description

This g roup (Cohort 2 as per protocol summary) consisted in patients aged 18 years or more with completely resected stage IB, II or III tumors who are due for chemotherapy, who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product after receiving cis-diaminedichloroplatine (CDDP) + vinorelbine [either Vinorelbine®or Pierre Fabre’s Navelbine®] chemotherapy. The 8-dose course of MAGE-A3 ASCI was administered according to a 3-week intervals schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to receive at least 2 cycles of chemotherapy ,(1 standard dose of CDDP and of vinorelbine intravenously on the first day of each cycle and 1 dose of vinorelbine on Day 8 of each cycle), the last dose received to 4 weeks prior Dose 1 of MAGE-A3 ASCI. No additional chemotherapy was administered to patients from Week 0 onwards.

Reporting group title

MAGE-A3 ASCI Group

Reporting group description

Reporting group title

Chemo/radiotherapy-MAGE-A3 ASCI Group

Reporting group description

This group (Cohort 4 as per protocol summary) consisted in patients aged 18 years or more with unresectable stage III tumors following chemotherapy and radiotherapy who received 8 doses of the GSK1572932A (or MAGE-A3 ASCI) study product. The 8-dose course of MAGE-A3 ASCI study product was to be administered according to a 3-week intervals administration schedule, at Weeks 0, 3, 6, 9, 12, 15, 18 and 21, intramuscularly in the deltoid or lateral region of the thigh, alternating left and right side, irrespective of the patient's body weight or area. Patients were to have received their last dose of chemotherapy (cis-diaminedichloroplatine [CDDP] + vinorelbine [either the generic Vinorelbine®or Pierre Fabre’s Navelbine®]) and/or radiotherapy 2 to 6 weeks prior to receiving Dose 1 of MAGE-A3 ASCI product. No additional chemo-/radiotherapy was administered to patients in this cohort from Week 0 onwards.

Serious adverse events	Chemotherapy + MAGE-A3 Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 19 (63.16%)	0 / 18 (0.00%)	4 / 18 (22.22%)	3 / 12 (25.00%)
number of deaths (all causes)	0	0	0	1
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Contusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Thrombosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	6 / 19 (31.58%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	5 / 19 (26.32%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mucosal inflammation
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Nausea
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchial haemorrhage
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic failure
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Urticaria chronic
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Chemotherapy + MAGE-A3 Group	Chemotherapy/MAGE-A3 ASCI Group	MAGE-A3 ASCI Group	Chemo/radiotherapy-MAGE-A3 ASCI Group
Total subjects affected by non serious adverse events
subjects affected / exposed	19 / 19 (100.00%)	18 / 18 (100.00%)	17 / 18 (94.44%)	11 / 12 (91.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Vascular disorders
Arterial disorder
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Arteriosclerosis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Haematoma
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Hypertension
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	1	0	1	0
Orthostatic hypotension
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Peripheral coldness
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Phlebitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Phlebitis superficial
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Raynaud’s phenomenon
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Thrombosis
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
General disorders and administration site conditions
Administration site pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1
Administration site reaction
subjects affected / exposed	4 / 19 (21.05%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	4	0	0	0
Asthenia
subjects affected / exposed	7 / 19 (36.84%)	0 / 18 (0.00%)	2 / 18 (11.11%)	1 / 12 (8.33%)
occurrences all number	7	0	2	1
Axillary pain
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Chest pain
subjects affected / exposed	1 / 19 (5.26%)	1 / 18 (5.56%)	1 / 18 (5.56%)	1 / 12 (8.33%)
occurrences all number	1	1	1	1
Chills
subjects affected / exposed	0 / 19 (0.00%)	4 / 18 (22.22%)	3 / 18 (16.67%)	2 / 12 (16.67%)
occurrences all number	0	4	3	2
Fatigue
alternative assessment type: Systematic
subjects affected / exposed	5 / 19 (26.32%)	5 / 18 (27.78%)	3 / 18 (16.67%)	1 / 12 (8.33%)
occurrences all number	5	5	3	1
Gait disturbance
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Hypothermia
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Influenza like illness
subjects affected / exposed	2 / 19 (10.53%)	1 / 18 (5.56%)	5 / 18 (27.78%)	2 / 12 (16.67%)
occurrences all number	2	1	5	2
Injection site coldness
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Injection site erythema
subjects affected / exposed	0 / 19 (0.00%)	3 / 18 (16.67%)	2 / 18 (11.11%)	1 / 12 (8.33%)
occurrences all number	0	3	2	1
Injection site haematoma
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	2	0	1	0
Injection site inflammation
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	4 / 18 (22.22%)	0 / 12 (0.00%)
occurrences all number	0	0	4	0
Injection site oedema
subjects affected / exposed	4 / 19 (21.05%)	2 / 18 (11.11%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	4	2	0	0
Injection site pain
subjects affected / exposed	5 / 19 (26.32%)	10 / 18 (55.56%)	12 / 18 (66.67%)	3 / 12 (25.00%)
occurrences all number	5	10	12	3
Injection site pruritus
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Injection site rash
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Injection site reaction
subjects affected / exposed	10 / 19 (52.63%)	3 / 18 (16.67%)	2 / 18 (11.11%)	2 / 12 (16.67%)
occurrences all number	10	3	2	2
Injection site swelling
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Malaise
subjects affected / exposed	0 / 19 (0.00%)	2 / 18 (11.11%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	2	0	0
Mucosal inflammation
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Oedema
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Pain
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Pyrexia
subjects affected / exposed	7 / 19 (36.84%)	6 / 18 (33.33%)	5 / 18 (27.78%)	4 / 12 (33.33%)
occurrences all number	7	6	5	4
Sense of oppression
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Bronchial haemorrhage
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Bronchitis chronic
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Cough
subjects affected / exposed	2 / 19 (10.53%)	3 / 18 (16.67%)	2 / 18 (11.11%)	2 / 12 (16.67%)
occurrences all number	2	3	2	2
Dysphonia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Dyspnoea
subjects affected / exposed	3 / 19 (15.79%)	1 / 18 (5.56%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	3	1	1	0
Epistaxis
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Hiccups
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	1 / 19 (5.26%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	1	0	0
Pleural effusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)
occurrences all number	0	0	1	1
Pleurisy
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Pulmonary embolism
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Sputum discoloured
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 19 (5.26%)	2 / 18 (11.11%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	2	0	0
Depression
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Insomnia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	1	0	1	0
Investigations
Lymphocyte count decreased
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Urine output decreased
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Weight decreased
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Weight increased
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Contusion
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Radiation pneumonitis
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Wound
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Cardiac disorders
Cardiac failure
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Cardiac failure acute
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Tachycardia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Nervous system disorders
Cervicobrachial syndrome
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Dizziness
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0
Dysaesthesia
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Headache
subjects affected / exposed	4 / 19 (21.05%)	5 / 18 (27.78%)	2 / 18 (11.11%)	0 / 12 (0.00%)
occurrences all number	4	5	2	0
Intercostal neuralgia
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Nervous system disorder
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Neuropathy peripheral
subjects affected / exposed	0 / 19 (0.00%)	3 / 18 (16.67%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	3	0	0
Paraesthesia
subjects affected / exposed	1 / 19 (5.26%)	3 / 18 (16.67%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	3	0	1
Peripheral sensory neuropathy
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Polyneuropathy
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Sinus headache
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Somnolence
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1
Tremor
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	6 / 19 (31.58%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	6	0	0	0
Febrile neutropenia
subjects affected / exposed	5 / 19 (26.32%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	5	0	0	0
Iron deficiency anaemia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Leukopenia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Monocytosis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Neutropenia
subjects affected / exposed	7 / 19 (36.84%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	7	0	0	0
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Tinnitus
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Vertigo
subjects affected / exposed	1 / 19 (5.26%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1	0	1
Eye disorders
Periorbital oedema
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0
Abdominal pain
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1
Abdominal pain upper
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1
Constipation
subjects affected / exposed	7 / 19 (36.84%)	2 / 18 (11.11%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	7	2	0	0
Diarrhoea
subjects affected / exposed	5 / 19 (26.32%)	1 / 18 (5.56%)	3 / 18 (16.67%)	0 / 12 (0.00%)
occurrences all number	5	1	3	0
Flatulence
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorder
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Loose tooth
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Mouth ulceration
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Nausea
subjects affected / exposed	7 / 19 (36.84%)	5 / 18 (27.78%)	1 / 18 (5.56%)	1 / 12 (8.33%)
occurrences all number	7	5	1	1
Regurgitation
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Stomatitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Vomiting
subjects affected / exposed	6 / 19 (31.58%)	6 / 18 (33.33%)	2 / 18 (11.11%)	0 / 12 (0.00%)
occurrences all number	6	6	2	0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Hepatic failure
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Alopecia
subjects affected / exposed	4 / 19 (21.05%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	4	0	1	0
Dermatitis
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Dry skin
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0
Erythema
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Night sweats
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Skin discolouration
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Urticaria
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Renal failure
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Renal pain
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 19 (15.79%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)
occurrences all number	3	0	1	1
Back pain
subjects affected / exposed	1 / 19 (5.26%)	2 / 18 (11.11%)	3 / 18 (16.67%)	1 / 12 (8.33%)
occurrences all number	1	2	3	1
Bone pain
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Muscle spasms
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Musculoskeletal pain
subjects affected / exposed	2 / 19 (10.53%)	3 / 18 (16.67%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	3	0	0
Myalgia
subjects affected / exposed	3 / 19 (15.79%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	3	1	0	0
Osteopenia
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Pain in extremity
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	1 / 18 (5.56%)	3 / 12 (25.00%)
occurrences all number	2	0	1	3
Gingivitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Influenza
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)
occurrences all number	2	0	1	1
Lobar pneumonia
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Lower respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Nasopharyngitis
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	1 / 18 (5.56%)	2 / 12 (16.67%)
occurrences all number	1	0	1	2
Paronychia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Pneumonia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	0	0	2
Rhinitis
subjects affected / exposed	0 / 19 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	1	1	0
Upper respiratory tract infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0
Vulvovaginal mycotic infection
subjects affected / exposed	0 / 19 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	3 / 19 (15.79%)	2 / 18 (11.11%)	2 / 18 (11.11%)	1 / 12 (8.33%)
occurrences all number	3	2	2	1
Hypercholesterolaemia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Hypokalaemia
subjects affected / exposed	1 / 19 (5.26%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0
Hypomagnesaemia
subjects affected / exposed	5 / 19 (26.32%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	5	1	0	0
Iron deficiency
subjects affected / exposed	2 / 19 (10.53%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0

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Were there any global substantial amendments to the protocol? Yes

09 Mar 2009

In Amendment 1, dated 9 March 2009, the following changes were made: 1 /The patient population for Cohorts 1, 2 and 3 was modified from resected stage IB, II or IIIA to completely resected stage IA, IIB or III (with the exception of stage III N2 and N3) to allow enrolment of patients with completely resected T4 primary tumor with satellite lesions in the same lobe (stage IIIB). 2/ The recruitment period was extended to increase the feasibility of the study i.e. to facilitate enrolment and ensure that the targeted number of patients was reached. 3/The inclusion of tissue from lymph nodes as screening material was allowed to enable the screening and enrolment of patients with a less accessible primary tumor, which was especially important for patients in Cohort 4 (i.e. patients with unresectable stage III tumors, for whom no surgical material was obtained). 4/The time window between surgery/previous therapy and the first ASCI administration was extended for 2 cohorts i.e. 4 to 12 weeks for patients in Cohort 1, and 2 to 6 weeks for patients in Cohort 4. 5/The replacement of patients from Cohort 1 who withdrew because of an adverse event resulting from chemotherapy before the first ASCI administration was permitted. 6/ The sections regarding immunological assays were updated to include extension of the immune response analysis with assessment of anti-Cytosine Phosphate Guanosine oligodeoxynucleotide (CpG) antibody responses and analysis of antigen spreading.

06 Jan 2011

In Protocol Amendment 2, dated 6 January 2011, the following changes were made: 1/The description of the study product was changed to the 2-vial presentation, as the 3-vial presentation was no longer manufactured. 2/The handling instructions were updated to increase the allowed delay and allowed temperature between reconstitution of the study product and administration. 3/ In addition, the sections on the storage of the study product and study contact for reporting SAEs were also updated.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
05 Aug 2013	The study was terminated early on 5 August 2008, due to slow recruitment and difficulties to achieve the required patient population in the cohort 4. Enrolment and study procedures for patients enrolled in the other 3 groups took place as per planned.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

An analysis for anti-CpG immunogenicity was planned but not performed as the related test remains under development & it is not foreseen by GSK Biologicals that this immunogenicity has association with clinical benefit.

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Clinical trials

Clinical Trial Results: A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III).

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Concentrations for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Concentrations for anti-Melanoma AntiGEn (MAGE)-A3 antibodies

Primary: Number of subjects seropositive for anti-protein D (PD) antibodies

Primary: Number of subjects seropositive for anti-protein D (PD) antibodies

Primary: Number of humoral responders as regards anti-protein D (PD) antibodies

Primary: Number of humoral responders as regards anti-protein D (PD) antibodies

Primary: Concentrations for anti-protein D (PD) antibodies

Primary: Concentrations for anti-protein D (PD) antibodies

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)4 T-cell immunogenicity

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

Primary: Number of patients seropositive as regards MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

Primary: Number of patients responders as MAGE-A3 Cluster of Differentiation (CD)8 T-cell immunogenicity

Primary: Number of patients with abnormal haemoglobin laboratory values by maximum grade

Primary: Number of patients with abnormal haemoglobin laboratory values by maximum grade

Primary: Number of patients with abnormal leukocytes laboratory values by maximum grade

Primary: Number of patients with abnormal leukocytes laboratory values by maximum grade

Primary: Number of patients with abnormal lymphopenia laboratory values by maximum grade

Primary: Number of patients with abnormal lymphopenia laboratory values by maximum grade

Primary: Number of patients with abnormal neutrophils laboratory values by maximum grade

Primary: Number of patients with abnormal neutrophils laboratory values by maximum grade

Primary: Number of patients with abnormal platelets laboratory values by maximum grade

Primary: Number of patients with abnormal platelets laboratory values by maximum grade

Primary: Number of patients with adverse events (AEs) by maximum grade

Primary: Number of patients with adverse events (AEs) by maximum grade

Primary: Number of patients with potential immune-mediated diseases (pIMDs)

Primary: Number of patients with potential immune-mediated diseases (pIMDs)

Primary: Number of patients with unsolicited adverse events (AEs), irrespective of grade

Primary: Number of patients with unsolicited adverse events (AEs), irrespective of grade

Primary: Number of patients with serious adverse events (SAEs)

Primary: Number of patients with serious adverse events (SAEs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III).