NCT02301039 · STUDY IN CONTEXT

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced 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. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.

There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.

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secondary · POSTED

Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.

Source null

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secondary · POSTED

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Source null

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secondary · POSTED

Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions

There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort.

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secondary · POSTED

The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive

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-bone-sarcoma
nct id: NCT02301039
trial label: SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced 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.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 5
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0000
source section id
NCT02301039-om-0000
source outcome index
0
endpoint
Objective Response Rate
endpoint definition
The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.
time origin
Assessments will be conducted at 8 weeks, up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.
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-bone-sarcoma
nct id
NCT02301039
outcome key
om-0001
source section id
NCT02301039-om-0001
source outcome index
1
endpoint
Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient
endpoint definition
Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.
time origin
Up to 5 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-bone-sarcoma
nct id
NCT02301039
outcome key
om-0002
source section id
NCT02301039-om-0002
source outcome index
2
endpoint
The Progression-free Survival (PFS)
endpoint definition
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
time origin
up to 5 yrs
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-bone-sarcoma
nct id
NCT02301039
outcome key
om-0003
source section id
NCT02301039-om-0003
source outcome index
3
endpoint
Response Rate by Immune-related Response Criteria (Ir-RC)
endpoint definition
Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions
time origin
Assessment at 8 weeks, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort.
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-bone-sarcoma
nct id
NCT02301039
outcome key
om-0004
source section id
NCT02301039-om-0004
source outcome index
4
endpoint
Overall Survival (OS)
endpoint definition
The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive
time origin
up to 5 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-bone-sarcoma
nct id
NCT02301039
outcome key
om-0000
arm key
OG000
arm label
Soft Tissue Sarcoma
regimen
Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0000
arm key
OG001
arm label
Bone Sarcoma
regimen
Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0000
arm key
OG002
arm label
Expansion Cohort
regimen
Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
analyzed count
53
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0001
arm key
OG000
arm label
Soft Tissue Sarcoma
regimen
Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0001
arm key
OG001
arm label
Bone Sarcoma
regimen
Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0001
arm key
OG002
arm label
Expansion Cohort
regimen
Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0002
arm key
OG000
arm label
Soft Tissue Sarcoma
regimen
Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0002
arm key
OG001
arm label
Bone Sarcoma
regimen
Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0002
arm key
OG002
arm label
Expansion Cohort
regimen
Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
analyzed count
53
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0003
arm key
OG000
arm label
Soft Tissue Sarcoma
regimen
Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0003
arm key
OG001
arm label
Bone Sarcoma
regimen
Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
outcome key
om-0003
arm key
OG002
arm label
Expansion Cohort
regimen
Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
analyzed count
52
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02301039-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-bone-sarcoma
nct id
NCT02301039
harm key
EG000
source section id
NCT02301039-ae
event group key
EG000
event group label
Soft Tissue Sarcoma
serious affected
19
serious at risk
42
other affected
40
other at risk
42
frequency threshold
1
collection period
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
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-bone-sarcoma
nct id
NCT02301039
harm key
EG001
source section id
NCT02301039-ae
event group key
EG001
event group label
Bone Sarcoma
serious affected
15
serious at risk
42
other affected
42
other at risk
42
frequency threshold
1
collection period
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
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-bone-sarcoma
nct id
NCT02301039
harm key
EG002
source section id
NCT02301039-ae
event group key
EG002
event group label
Expansion
serious affected
17
serious at risk
60
other affected
58
other at risk
60
frequency threshold
1
collection period
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
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