Trial Outcomes & Findings for A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma (NCT NCT00942162)
NCT ID: NCT00942162
Last Updated: 2020-12-08
Results Overview
The 1-year overall survival rate (OSR) in the GS+ Population would be above 50% (target = 71%), a percentage which was reported together with its 95% confidence interval (CI). Maximum 1-year OSR of any currently available treatment in the MAGE-A3-positive population = 50% (P0). This median OS of 12 months is based on the observed median OS for MAGE-A3-positive patients, whose tumor did not present the predictive GS. The target 1-year OSR for patients presenting the predictive GS = 71% (P1). This corresponds to a median OS of 24 months when assuming an exponential distribution of OS.
COMPLETED
PHASE2
125 participants
Month 0 - Month 12
2020-12-08
Participant Flow
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the patients and signing informed consent forms. While 125 subjects were enrolled, only 123 started the study, as 2 subjects did not receive treatment and were excluded.
Participant milestones
| Measure |
GSK2132231A GS+ Group
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
50
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
50
|
2
|
Reasons for withdrawal
| Measure |
GSK2132231A GS+ Group
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|
|
Overall Study
Death
|
45
|
35
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
0
|
|
Overall Study
Other
|
14
|
13
|
2
|
Baseline Characteristics
A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma
Baseline characteristics by cohort
| Measure |
GSK2132231A GS+ Group
n=71 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=50 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=2 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 13.9 • n=93 Participants
|
62.1 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
60.5 Years
STANDARD_DEVIATION 6.36 • n=27 Participants
|
64.9 Years
STANDARD_DEVIATION 13.45 • n=483 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
71 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
123 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Month 0 - Month 12Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment, but did not include patients who dropped out from the study (i.e. patients alive at the last evaluation visit and followed for less than 1 year at first database freeze).
The 1-year overall survival rate (OSR) in the GS+ Population would be above 50% (target = 71%), a percentage which was reported together with its 95% confidence interval (CI). Maximum 1-year OSR of any currently available treatment in the MAGE-A3-positive population = 50% (P0). This median OS of 12 months is based on the observed median OS for MAGE-A3-positive patients, whose tumor did not present the predictive GS. The target 1-year OSR for patients presenting the predictive GS = 71% (P1). This corresponds to a median OS of 24 months when assuming an exponential distribution of OS.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=65 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=48 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=2 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
One-year Overall Survival Rate (OSR) Estimated by Complete Case Method
|
83.08 Percentage of Participants
Interval 71.73 to 91.24
|
83.33 Percentage of Participants
Interval 69.78 to 92.52
|
100 Percentage of Participants
Interval 15.81 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Month 0 - Month 49Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients Reported With Serious Adverse Events (SAEs)
|
19 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment.
Cancer staging (characteristics and categories) as by the categorization by the American Joint Committee on Cancer (AJCC) Staging Manual 2002: "Stage IIIA patients have up to three microscopic nodal metastases arising from a non-ulcerating primary melanoma and have an ' intermediate risk' for distant metastases and melanom-specific survival. Stage IIIB patients have up to three microscopic nodal metastases arising from a non-ulcerating melanoma or have up to three microscopic nodal metastases arising from an ulcerating melanoma, or have intralymphatic metastases without nodal metastases. They constitute a 'high-risk' group prognostically." The remaining patients with regional melanoma are Stage IIIC patients are at 'very high risk' for distant metastases and melanoma-specific mortality. Stage IV melanoma patients have metastasis at any distant site and constitute the group with the worst prognosis. Stage MC patients are those with confirmed missing cancer.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=71 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=50 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=2 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Diseases Characteristics by GS
STAGE MC
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Patients With Diseases Characteristics by GS
STAGE IIIA
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Patients With Diseases Characteristics by GS
STAGE IIIB
|
11 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Patients With Diseases Characteristics by GS
STAGE IIIC
|
21 Participants
|
19 Participants
|
1 Participants
|
—
|
|
Number of Patients With Diseases Characteristics by GS
STAGE IV
|
39 Participants
|
27 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 24Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. PFS was not assessed in the MAGE-A3 Unknown GS Group.
From study start (Month 0) to Month 24, each patient was censored out of the analysis at 1st report of disease progression or death. PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=71 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=50 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) by GS
|
2.8 Months
Interval 2.8 to 2.8
|
2.8 Months
Interval 2.8 to 2.9
|
2.8 Months
Interval 2.5 to 2.8
|
—
|
SECONDARY outcome
Timeframe: Month 6, Month 12, Month 24Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. PFS was not assessed in the GSK2132231A GS-unknown Group.
PFS was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death, whichever comes first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. The PFS estimates were assessed by the Kaplan-Meier method and expressed as the percentage of patients who did not progress and were alive at a given time.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=71 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=50 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Kaplan-Meier Estimates of the Progression-free Survival (PFS) at Months 6, 12 and 24, by Gene Signature
PFS 6M
|
13.53 Percentage of patients
Interval 6.71 to 22.75
|
5 Percentage of patients
Interval 1.0 to 14.22
|
—
|
—
|
|
Kaplan-Meier Estimates of the Progression-free Survival (PFS) at Months 6, 12 and 24, by Gene Signature
PFS 12M
|
6.02 Percentage of patients
Interval 1.95 to 13.43
|
5 Percentage of patients
Interval 1.0 to 14.22
|
—
|
—
|
|
Kaplan-Meier Estimates of the Progression-free Survival (PFS) at Months 6, 12 and 24, by Gene Signature
PFS 24M
|
1.5 Percentage of patients
Interval 0.13 to 7.12
|
5 Percentage of patients
Interval 1.0 to 14.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years from the time of registration.Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. OS was not assessed in the GSK2132231A GS-unknown Group.
OS was defined as the time from registration of the patient until death, with patients alive at the time of analysis censored at the time of the last contact.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=71 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=50 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Overall Survival (OS) by GS
|
23.9 Months
Interval 19.2 to 28.2
|
20.6 Months
Interval 16.1 to 28.2
|
25.8 Months
Interval 18.4 to 35.5
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 24Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. TTF was not assessed in the GSK2132231A GS-unknown Group.
The TTF was defined as the time from registration of the patient until the date of the last treatment administration, irrespective of the reason for study treatment discontinuation.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=71 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=50 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Time to Treatment Failure (TTF) by GS
|
2.5 Months
Interval 2.4 to 4.1
|
2.7 Months
Interval 2.4 to 5.4
|
2.4 Months
Interval 2.3 to 2.6
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 24Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment.
The BOR was the best response recorded from the start of the treatment until disease progression/ recurrence, except for confirmed objective response, which was reported as BOR independently of its time of occurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions without any new lesions and/or progression of existing non-target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD) without any new lesions and/or progression of existing non-target lesions; PD, \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; NE = Non-evaluable response.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=71 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=50 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=2 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Best Overall Response (BOR) by GS
SD
|
11 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Best Overall Response (BOR) by GS
CR
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Best Overall Response (BOR) by GS
PR
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response (BOR) by GS
SD/ PR
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response (BOR) by GS
PD
|
51 Participants
|
44 Participants
|
2 Participants
|
—
|
|
Best Overall Response (BOR) by GS
NE
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Best Overall Response (BOR) by GS
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 24Population: The analysis was performed on the Responders Population, including patients with an objective response \[complete (CR) or partial response (PR)\] as best overall clinical response as confirmed by repeated assessments performed at least 4 weeks apart at the time of analysis.
Duration of response was measured from the time when the measurement criteria for CR/ PR (whichever was recorded first) were met until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Note: As there was only one patient analysed in the GSK2132231A GS- Group, the median duration of response was not calculated for this latter group.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=4 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=3 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Duration of Response (CR or PR)
|
8.3 Months
Interval 1.9 to 8.3
|
6.9 Months
Interval 1.9 to 9.7
|
NA Months
Median duration of response cannot be calculated as number analyzed =1.
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 24Population: The analysis was performed on the Stable Disease Population, which included the patients whose best response was stable disease. To qualify as SD for the best overall response, the patient should be in a SD status for a minimum of 12 weeks, as documented by two consecutive visits 12 weeks apart, or a SD status 12 weeks after baseline evaluation.
The duration of stable disease (SD), or TTP, was tabulated for patients whose best response was SD. The minimal time interval required between 2 measurements for determination of SD was 12 weeks.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=15 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=11 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=4 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Duration of Stable Disease (SD), or Time-to-Progression (TTP) by GS
|
5.4 Months
Interval 5.1 to 9.4
|
5.4 Months
Interval 4.1 to 9.4
|
5.4 Months
Interval 5.1 to 25.0
|
—
|
SECONDARY outcome
Timeframe: PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49).Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Seropositive patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=87 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=52 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=34 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PRE
|
7 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PII(W4)
|
60 Participants
|
37 Participants
|
22 Participants
|
1 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PVI(W12)
|
52 Participants
|
34 Participants
|
17 Participants
|
1 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PXII(W31)
|
11 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PXVI(W54)
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PXVII(M18)
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Anti-MAGE-A3
Anti-MAGE-A3, PXXIV(M49)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=87 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=52 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=34 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PRE
|
11.2 EL.U/mL
Interval 10.3 to 12.2
|
11.2 EL.U/mL
Interval 10.0 to 12.5
|
11.3 EL.U/mL
Interval 9.8 to 13.0
|
10.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PII(W4)
|
906.1 EL.U/mL
Interval 608.0 to 1350.2
|
728.7 EL.U/mL
Interval 406.0 to 1307.9
|
1385.7 EL.U/mL
Interval 896.4 to 2142.0
|
387.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PVI(W12)
|
6190.1 EL.U/mL
Interval 5007.6 to 7652.0
|
5631 EL.U/mL
Interval 4284.9 to 7399.8
|
7500.1 EL.U/mL
Interval 5165.9 to 10889.2
|
5921.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PXII(W31)
|
6724.2 EL.U/mL
Interval 3978.0 to 11366.4
|
7094.2 EL.U/mL
Interval 2360.0 to 21325.5
|
6430.7 EL.U/mL
Interval 2877.3 to 14372.4
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PXVI(W54)
|
3289.8 EL.U/mL
Interval 1575.4 to 6870.0
|
2570.9 EL.U/mL
Interval 480.1 to 13765.9
|
4209.7 EL.U/mL
Interval 622.4 to 28473.7
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PXVII(M18)
|
4118.6 EL.U/mL
Interval 1557.3 to 10892.7
|
4784.5 EL.U/mL
Interval 115.5 to 198255.8
|
3052.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PXXIV(M49)
|
7063.9 EL.U/mL
Interval 3780.4 to 13199.4
|
7063.9 EL.U/mL
Interval 3780.4 to 13199.4
|
—
|
—
|
SECONDARY outcome
Timeframe: PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Seropositive patients were those patients with anti-PD antibody concentrations ≥ 100 EL.U/mL.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=88 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=53 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=34 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Seropositive Patients for Protein D
Anti-PD, PRE
|
29 Participants
|
20 Participants
|
8 Participants
|
1 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PII (W4)
|
77 Participants
|
46 Participants
|
30 Participants
|
1 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PVI (W12)
|
52 Participants
|
34 Participants
|
17 Participants
|
1 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PXII (W31)
|
11 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PXVI (W54)
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PXVII (M18)
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seropositive Patients for Protein D
Anti-PD, PXXIV (M49)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=88 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=53 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=34 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PRE
|
81.2 EL.U/mL
Interval 68.5 to 96.2
|
86.1 EL.U/mL
Interval 68.9 to 107.5
|
70.6 EL.U/mL
Interval 54.5 to 91.5
|
412.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PII (W4)
|
4588 EL.U/mL
Interval 3397.5 to 6195.7
|
4196.9 EL.U/mL
Interval 2768.0 to 6363.3
|
5139.8 EL.U/mL
Interval 3253.3 to 8120.2
|
9167.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PVI (W12)
|
15036.7 EL.U/mL
Interval 12057.7 to 18751.5
|
14091.9 EL.U/mL
Interval 10763.7 to 18449.4
|
16453.2 EL.U/mL
Interval 10607.9 to 25519.6
|
29553.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PXII (W31)
|
23548.6 EL.U/mL
Interval 15167.2 to 36561.6
|
25070.5 EL.U/mL
Interval 8468.5 to 74220.0
|
22351.2 EL.U/mL
Interval 13378.0 to 37343.1
|
—
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PXVI(W54)
|
12389.9 EL.U/mL
Interval 6229.0 to 24644.4
|
9639.2 EL.U/mL
Interval 1286.9 to 72202.6
|
15925.5 EL.U/mL
Interval 4872.0 to 52057.0
|
—
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PXVII (M18)
|
11386.1 EL.U/mL
Interval 3141.7 to 41265.3
|
13839.4 EL.U/mL
Interval 93.9 to 2040751.0
|
7707.0 EL.U/mL
The limits of the CI can not be calculated as number analyzed =1.
|
—
|
|
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD, PXXIV (M49)
|
10546.9 EL.U/mL
Interval 1777.2 to 62591.1
|
10546.9 EL.U/mL
Interval 1777.2 to 62591.1
|
—
|
—
|
SECONDARY outcome
Timeframe: PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Anti-MAGE-A3 antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EL.U/mL; For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=62 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=39 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=22 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PXXIV (M49)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PII (W4)
|
60 Participants
|
37 Participants
|
22 Participants
|
1 Participants
|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PVI (W12)
|
52 Participants
|
34 Participants
|
17 Participants
|
1 Participants
|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PXII (W31)
|
11 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PXVI (W54)
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, PXVII (M18)
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)Population: The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.
Anti-PD antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 100 EL.U/mL; For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=77 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
n=46 Participants
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=30 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
n=1 Participants
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Anti-PD Antibody Response
Anti-PD, PVI (W12)
|
52 Participants
|
34 Participants
|
17 Participants
|
1 Participants
|
|
Anti-PD Antibody Response
Anti-PD, PXXIV (M49)
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Anti-PD Antibody Response
Anti-PD, PII (W4)
|
76 Participants
|
45 Participants
|
30 Participants
|
1 Participants
|
|
Anti-PD Antibody Response
Anti-PD, PXII (W31)
|
11 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Anti-PD Antibody Response
Anti-PD, PXVI (W54)
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Anti-PD Antibody Response
Anti-PD, PXVII (M18)
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G0
|
100 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G1
|
8 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G3
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; SE G0
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; SE G1
|
8 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; SE G2
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G1
|
12 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G0
|
101 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; SE G0
|
6 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; SE G1
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G0
|
103 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G1
|
7 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G1; SE G0
|
5 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G1; SE G1
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G0
|
113 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G1; SE G0
|
2 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G2; SE G1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G2; SE G2
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G0
|
105 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G1
|
7 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G1
|
6 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G2
|
2 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; SE G2
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G0
|
61 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G1
|
30 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G3
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G1
|
16 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G2
|
6 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G3
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G4
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; SE G0
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; SE G2
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G4, and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G0
|
6 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G0
|
99 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G1
|
10 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G4
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G1
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; SE G1
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G2
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G0
|
67 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G1
|
18 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G0
|
3 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G1
|
23 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G2
|
4 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G2; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G2; SE G3
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G3; SE G3
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; SE G1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G0
|
108 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G1
|
4 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; SE G0
|
2 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; SE G1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; SE G3
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49 (each patient was censored out of the analysis at time of death)Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.
The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G4, and Unknown (UNK).
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G0
|
112 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G4
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G1; SE G1
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0 - Month 49Population: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.
Auto-immune diseases or immune-mediated inflammatory disorders were tabulated during the whole duration of the study (up to 30 days after the last administration of the study treatment). The results were tabulated as Any event(s) reported.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients With Autoimmune Diseases or Immune-mediated Inflammatory Disorders
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 30 days after the last administration of the study treatment, approximately 49 monthsPopulation: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.
The assessed AEs were ASCI-related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death due to AE. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient 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.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.
Any event, Grade 1
|
52 Participants
|
—
|
—
|
—
|
|
Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.
Any event, Grade 2
|
35 Participants
|
—
|
—
|
—
|
|
Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.
Any event, Grade 3
|
21 Participants
|
—
|
—
|
—
|
|
Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.
Any event, Grade 4
|
5 Participants
|
—
|
—
|
—
|
|
Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.
Any event, Grade 5
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 30 days after the last administration of the study treatment, approximately 49 monthsPopulation: The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient 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.
Outcome measures
| Measure |
GSK2132231A GS+ Group
n=123 Participants
Patients with the pre-specified gene signature (GS), who received intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS- Group
Patients without the pre-specified gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
GSK2132231A GS-unknown Group
Patients with unknown gene signature (GS), planned to receive intramuscularly up to 24 doses of MAGE\_A3 ASCI (the study product), in 4 cycles. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
|
|---|---|---|---|---|
|
Number of Patients Reported With Unsolicited AE(s)
|
116 Participants
|
—
|
—
|
—
|
Adverse Events
Overall Study Group
Serious adverse events
| Measure |
Overall Study Group
n=123 participants at risk
Group of all patients (GS+, GS- and Unknown GS) planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.
|
|---|---|
|
Vascular disorders
Lymphoedema
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Vascular disorders
Phlebitis
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Nervous system disorders
Cognitive disorder
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Nervous system disorders
Hypotonia
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Multi-organ failure
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Renal and urinary disorders
Renal colic
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Infections and infestations
Erysipelas
|
0.81%
1/123 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
Other adverse events
| Measure |
Overall Study Group
n=123 participants at risk
Group of all patients (GS+, GS- and Unknown GS) planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
9/123 • Number of events 12 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Asthenia
|
13.8%
17/123 • Number of events 42 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Chills
|
17.1%
21/123 • Number of events 42 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Gastrointestinal disorders
Constipation
|
8.1%
10/123 • Number of events 22 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
8/123 • Number of events 10 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
13/123 • Number of events 32 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
7/123 • Number of events 20 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Fatigue
|
24.4%
30/123 • Number of events 110 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Nervous system disorders
Headache
|
11.4%
14/123 • Number of events 20 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Influenza like illness
|
12.2%
15/123 • Number of events 46 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Injection site erythema
|
17.1%
21/123 • Number of events 53 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Injection site pain
|
48.8%
60/123 • Number of events 193 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Injection site reaction
|
7.3%
9/123 • Number of events 38 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
12/123 • Number of events 96 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Gastrointestinal disorders
Nausea
|
12.2%
15/123 • Number of events 35 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Pain
|
8.9%
11/123 • Number of events 11 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.6%
18/123 • Number of events 25 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
|
General disorders
Pyrexia
|
33.3%
41/123 • Number of events 155 • AEs were collected up to 30 days after each treatment; SAEs were collected from Month 0 to Month 49.
As planned per study protocol, safety was assessed in the overall population regardless of GS status.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER