TriangleNCT01265433 · STUDY IN CONTEXT
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Median 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.
Median overall survival (OS) is estimated from time of randomization to all cause mortality
Immunogenicity of galinpepimut-S and control from a subset of participants
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- trial label
- Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0000
- source section id
- NCT01265433-om-0000
- source outcome index
- 0
- endpoint
- 1-year Progression-free Survival
- endpoint definition
- Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
- time origin
- 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0001
- source section id
- NCT01265433-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- Median 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.
- time origin
- Up to 5 years and 11 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0002
- source section id
- NCT01265433-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Median overall survival (OS) is estimated from time of randomization to all cause mortality
- time origin
- Uo to 5 years and 11 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0003
- source section id
- NCT01265433-om-0003
- source outcome index
- 3
- endpoint
- Immune Response
- endpoint definition
- Immunogenicity of galinpepimut-S and control from a subset of participants
- time origin
- 12 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were available from 22 participants only
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Galinpepimut-S
- regimen
- Galinpepimut-S + Montanide + GM-CSF
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Control
- regimen
- Montanide + GM-CSF
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Galinpepimut-S
- regimen
- Galinpepimut-S + Montanide + GM-CSF
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Control
- regimen
- Montanide + GM-CSF
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Galinpepimut-S
- regimen
- Galinpepimut-S + Montanide + GM-CSF
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Control
- regimen
- Montanide + GM-CSF
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Galinpepimut-S
- regimen
- Galinpepimut-S + Montanide + GM-CSF
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Control
- regimen
- Montanide + GM-CSF
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01265433-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- harm key
- EG000
- source section id
- NCT01265433-ae
- event group key
- EG000
- event group label
- Galinpepimut-S
- serious affected
- 1
- serious at risk
- 20
- other affected
- 17
- other at risk
- 20
- frequency threshold
- 0
- collection period
- Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01265433
- harm key
- EG001
- source section id
- NCT01265433-ae
- event group key
- EG001
- event group label
- Control
- serious affected
- 1
- serious at risk
- 21
- other affected
- 10
- other at risk
- 21
- frequency threshold
- 0
- collection period
- Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice