NCT03899805 · STUDY IN CONTEXT

A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

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.

primary · POSTED

12-week PFS was defined as the percent probability estimate at 12 weeks based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Source null

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secondary · POSTED

Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.

Source null

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secondary · POSTED

ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Source null

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secondary · POSTED

CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1

Source null

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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-liposarcoma
nct id: NCT03899805
trial label: A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas
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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0000
source section id
NCT03899805-om-0000
source outcome index
0
endpoint
12-week Progression Free Survival (PFS)
endpoint definition
12-week PFS was defined as the percent probability estimate at 12 weeks based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
time origin
12 weeks
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-liposarcoma
nct id
NCT03899805
outcome key
om-0001
source section id
NCT03899805-om-0001
source outcome index
1
endpoint
Median Overall Survival (OS)
endpoint definition
Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
time origin
Up to 2 years
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-liposarcoma
nct id
NCT03899805
outcome key
om-0002
source section id
NCT03899805-om-0002
source outcome index
2
endpoint
Objective Response Rate(ORR)
endpoint definition
ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
time origin
Up to 2 years
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-liposarcoma
nct id
NCT03899805
outcome key
om-0003
source section id
NCT03899805-om-0003
source outcome index
3
endpoint
Clinical Benefit Response Rate (CBR)
endpoint definition
CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1
time origin
Up to 2 years
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

arms

release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0000
arm key
OG000
arm label
Liposarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0000
arm key
OG001
arm label
Leiomyosarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0000
arm key
OG002
arm label
Undifferentiated Pleomorphic Sarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0001
arm key
OG000
arm label
Liposarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0001
arm key
OG001
arm label
Leiomyosarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0001
arm key
OG002
arm label
Undifferentiated Pleomorphic Sarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0002
arm key
OG000
arm label
Liposarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0002
arm key
OG001
arm label
Leiomyosarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0002
arm key
OG002
arm label
Undifferentiated Pleomorphic Sarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0003
arm key
OG000
arm label
Liposarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0003
arm key
OG001
arm label
Leiomyosarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
outcome key
om-0003
arm key
OG002
arm label
Undifferentiated Pleomorphic Sarcomas
regimen
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03899805-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-liposarcoma
nct id
NCT03899805
harm key
EG000
source section id
NCT03899805-ae
event group key
EG000
event group label
Liposarcomas
serious affected
9
serious at risk
20
other affected
20
other at risk
20
frequency threshold
0
collection period
Up to 2 years.
event definition
A serious adverse event (SAE) is any adverse event occurring at any dose that, 1) results in death; 2) is life threatening; 3) results in persistent or significant disability/incapacity; 4) results in or prolongs an existing inpatient hospitalization; 5) is a congenital anomaly/birth defect; 6) is a new cancer (that is not a condition of the study); 7) is associated with an overdose; 8) is another important medical event
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-liposarcoma
nct id
NCT03899805
harm key
EG001
source section id
NCT03899805-ae
event group key
EG001
event group label
Leiomyosarcomas
serious affected
8
serious at risk
19
other affected
19
other at risk
19
frequency threshold
0
collection period
Up to 2 years.
event definition
A serious adverse event (SAE) is any adverse event occurring at any dose that, 1) results in death; 2) is life threatening; 3) results in persistent or significant disability/incapacity; 4) results in or prolongs an existing inpatient hospitalization; 5) is a congenital anomaly/birth defect; 6) is a new cancer (that is not a condition of the study); 7) is associated with an overdose; 8) is another important medical event
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-liposarcoma
nct id
NCT03899805
harm key
EG002
source section id
NCT03899805-ae
event group key
EG002
event group label
Undifferentiated Pleomorphic Sarcomas
serious affected
8
serious at risk
18
other affected
18
other at risk
18
frequency threshold
0
collection period
Up to 2 years.
event definition
A serious adverse event (SAE) is any adverse event occurring at any dose that, 1) results in death; 2) is life threatening; 3) results in persistent or significant disability/incapacity; 4) results in or prolongs an existing inpatient hospitalization; 5) is a congenital anomaly/birth defect; 6) is a new cancer (that is not a condition of the study); 7) is associated with an overdose; 8) is another important medical event
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