Trial Outcomes & Findings for Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy (NCT NCT01265433)
NCT ID: NCT01265433
Last Updated: 2024-10-09
Results Overview
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
1 year
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Galinpepimut-S + Montanide + GM-CSF
Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
|
Montanide + GM-CSF
Montanide adjuvant + GM-CSF: Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Galinpepimut-S
n=20 Participants
Galinpepimut-s + Montanide + GM-CSF
|
Control
n=21 Participants
Montanide + GM-CSF
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=20 Participants
|
67 years
n=21 Participants
|
68 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
18 Participants
n=21 Participants
|
35 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Karnofsky performance status at enrollment
70%
|
1 Participants
n=20 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=41 Participants
|
|
Karnofsky performance status at enrollment
80%
|
7 Participants
n=20 Participants
|
12 Participants
n=21 Participants
|
19 Participants
n=41 Participants
|
|
Karnofsky performance status at enrollment
90%
|
11 Participants
n=20 Participants
|
6 Participants
n=21 Participants
|
17 Participants
n=41 Participants
|
|
Karnofsky performance status at enrollment
100%
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
|
Smoking status
Former
|
12 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
25 Participants
n=41 Participants
|
|
Smoking status
Current
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Smoking status
Never
|
8 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
16 Participants
n=41 Participants
|
|
Histology
Epithelioid
|
18 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
39 Participants
n=41 Participants
|
|
Histology
Mixed
|
2 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=41 Participants
|
|
Histology
Sarcomatoid
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 1 yearProgression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Outcome measures
| Measure |
Galinpepimut-S
n=20 Participants
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=21 Participants
Montanide + GM-CSF
|
|---|---|---|
|
1-year Progression-free Survival
|
44 percentage of participants
|
33 percentage of participants
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PRIMARY outcome
Timeframe: Up to 5 years and 11 monthsMedian progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
Outcome measures
| Measure |
Galinpepimut-S
n=20 Participants
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=21 Participants
Montanide + GM-CSF
|
|---|---|---|
|
Progression-free Survival
|
10.1 months
Interval 5.5 to 20.8
|
7.4 months
Interval 2.8 to 14.6
|
SECONDARY outcome
Timeframe: Uo to 5 years and 11 monthsMedian overall survival (OS) is estimated from time of randomization to all cause mortality
Outcome measures
| Measure |
Galinpepimut-S
n=20 Participants
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=21 Participants
Montanide + GM-CSF
|
|---|---|---|
|
Overall Survival
|
22.8 months
Interval 9.1 to 37.6
|
18.3 months
Interval 10.2 to 28.0
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SECONDARY outcome
Timeframe: 12 weeksPopulation: Data were available from 22 participants only
Immunogenicity of galinpepimut-S and control from a subset of participants
Outcome measures
| Measure |
Galinpepimut-S
n=10 Participants
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=12 Participants
Montanide + GM-CSF
|
|---|---|---|
|
Immune Response
CD4 Elispot · Positive
|
4 Participants
|
1 Participants
|
|
Immune Response
CD4 Elispot · Negative
|
4 Participants
|
8 Participants
|
|
Immune Response
CD4 Elispot · Not tested
|
2 Participants
|
3 Participants
|
|
Immune Response
CD8 Elispot · Positive
|
1 Participants
|
1 Participants
|
|
Immune Response
CD8 Elispot · Negative
|
1 Participants
|
3 Participants
|
|
Immune Response
CD8 Elispot · Not tested
|
8 Participants
|
8 Participants
|
|
Immune Response
Tetramer assay positive · Positive
|
1 Participants
|
2 Participants
|
|
Immune Response
Tetramer assay positive · Negative
|
0 Participants
|
3 Participants
|
|
Immune Response
Tetramer assay positive · Not tested
|
9 Participants
|
7 Participants
|
Adverse Events
Galinpepimut-S
Serious events: 1 serious events
Other events: 17 other events
Deaths: 16 deaths
Control
Serious events: 1 serious events
Other events: 10 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Galinpepimut-S
n=20 participants at risk
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=21 participants at risk
Montanide + GM-CSF
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
4.8%
1/21 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
Other adverse events
| Measure |
Galinpepimut-S
n=20 participants at risk
Galinpepimut-S + Montanide + GM-CSF
|
Control
n=21 participants at risk
Montanide + GM-CSF
|
|---|---|---|
|
Surgical and medical procedures
Injection site reaction
|
85.0%
17/20 • Number of events 17 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
42.9%
9/21 • Number of events 9 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
General disorders
Fatigue
|
50.0%
10/20 • Number of events 10 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
47.6%
10/21 • Number of events 10 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
Immune system disorders
Fever
|
0.00%
0/20 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
19.0%
4/21 • Number of events 4 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
0.00%
0/20 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
9.5%
2/21 • Number of events 2 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
General disorders
Nausea
|
10.0%
2/20 • Number of events 2 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
0.00%
0/21 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
5.0%
1/20 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
4.8%
1/21 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
4.8%
1/21 • Number of events 1 • Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place