NCT03761914 · STUDY IN CONTEXT

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · POSTED

Time from enrollment to date of first confirmed disease progression or death whichever occurred earlier

Participants who received at least one dose of pembrolizumab (galinpepimut-S + pembrolizumab); mITT population. Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.

→

exploratory · POSTED

Time from enrollment to date of death from any cause

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primary · POSTED

Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1

Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.

→

primary · POSTED

Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirement). Overall response rate is defined as the proportion of participants with a best overall response of CR or PR as defined by RECIST 1.1

Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-small-cell-lung-cancer
nct id: NCT03761914
trial label: Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers
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-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0002
source section id
NCT03761914-om-0002
source outcome index
2
endpoint
Progression-free Survival (PFS) - Kaplan Meier Estimate
endpoint definition
Time from enrollment to date of first confirmed disease progression or death whichever occurred earlier
time origin
33 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of pembrolizumab (galinpepimut-S + pembrolizumab); mITT population. Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
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-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0003
source section id
NCT03761914-om-0003
source outcome index
3
endpoint
Overall Survival (OS) - Kaplan Meier Estimate
endpoint definition
Time from enrollment to date of death from any cause
time origin
33 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least one dose of pembrolizumab (galinpepimut-S + pembrolizumab); mITT population. Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
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-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0000
source section id
NCT03761914-om-0000
source outcome index
0
endpoint
Overall Response Rate (ORR) - Best Overall Response
endpoint definition
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
time origin
33 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
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-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0001
source section id
NCT03761914-om-0001
source outcome index
1
endpoint
Overall Response Rate (ORR) - Overall Response Rate
endpoint definition
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirement). Overall response rate is defined as the proportion of participants with a best overall response of CR or PR as defined by RECIST 1.1
time origin
33 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject from the Colorectal Cancer (CRC) arm enrolled but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
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-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0000
arm key
OG000
arm label
Ovarian Cancer (OvC)
regimen
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0000
arm key
OG001
arm label
Colorectal Cancer (CRC)
regimen
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0001
arm key
OG000
arm label
Ovarian Cancer (OvC)
regimen
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0001
arm key
OG001
arm label
Colorectal Cancer
regimen
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0002
arm key
OG000
arm label
Ovarian Cancer (OvC)
regimen
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0002
arm key
OG001
arm label
Colorectal Cancer
regimen
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0003
arm key
OG000
arm label
Ovarian Cancer (OvC)
regimen
* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
outcome key
om-0003
arm key
OG001
arm label
Colorectal Cancer
regimen
One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03761914-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03761914
harm key
EG000
source section id
NCT03761914-ae
event group key
EG000
event group label
Ovarian Cancer (OvC)
serious affected
5
serious at risk
25
other affected
25
other at risk
25
frequency threshold
5
collection period
Adverse event data was collected for 29 months.
event definition
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
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-small-cell-lung-cancer
nct id
NCT03761914
harm key
EG001
source section id
NCT03761914-ae
event group key
EG001
event group label
Colorectal Cancer (CRC)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Adverse event data was collected for 29 months.
event definition
All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
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