NCT02178722 · STUDY IN CONTEXT

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected 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.

primary · POSTED

An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.

The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

→

primary · POSTED

ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.

→

secondary · POSTED

Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.

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secondary · POSTED

Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.

→

secondary · POSTED

The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.

The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.

→

secondary · POSTED

Overall survival is determined from the date of first dose until death due to any cause.

The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.

→

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-gastric-cancer
nct id: NCT02178722
trial label: Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected 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: 6
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0000
source section id
NCT02178722-om-0000
source outcome index
0
endpoint
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
endpoint definition
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
time origin
Approximately 54 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0001
source section id
NCT02178722-om-0001
source outcome index
1
endpoint
Phase 2: Objective Response Rate (ORR)
endpoint definition
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
Approximately 54 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0002
source section id
NCT02178722-om-0002
source outcome index
2
endpoint
Phase 2: Duration of Response (DOR)
endpoint definition
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
time origin
Up to 54 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type and those who responded.
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0003
source section id
NCT02178722-om-0003
source outcome index
3
endpoint
Phase 2: Progression Free Survival (PFS)
endpoint definition
Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.
time origin
Up to 54 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0004
source section id
NCT02178722-om-0004
source outcome index
4
endpoint
Phase 2: Duration of Disease Control
endpoint definition
The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
time origin
Up to 54 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0005
source section id
NCT02178722-om-0005
source outcome index
5
endpoint
Phase 2: Overall Survival (OS)
endpoint definition
Overall survival is determined from the date of first dose until death due to any cause.
time origin
Up to 54 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.
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-gastric-cancer
nct id
NCT02178722
outcome key
om-0000
arm key
OG000
arm label
Phase 1: Epacadostat 25 mg BID
regimen
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0000
arm key
OG001
arm label
Phase 1: Epacadostat 50 mg BID
regimen
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0000
arm key
OG002
arm label
Phase 1: Epacadostat 100 mg BID
regimen
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0000
arm key
OG003
arm label
Phase 1: Epacadostat 300 mg BID
regimen
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0001
arm key
OG000
arm label
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
regimen
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
analyzed count
382
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0002
arm key
OG000
arm label
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
regimen
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
105
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0003
arm key
OG000
arm label
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
regimen
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
382
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0004
arm key
OG000
arm label
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
regimen
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
191
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
outcome key
om-0005
arm key
OG000
arm label
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
regimen
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
analyzed count
382
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02178722-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT02178722
harm key
EG000
source section id
NCT02178722-ae
event group key
EG000
event group label
Phase 1: Epacadostat 25 mg BID
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
harm key
EG001
source section id
NCT02178722-ae
event group key
EG001
event group label
Phase 1: Epacadostat 50 MG BID
serious affected
8
serious at risk
20
other affected
18
other at risk
20
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
harm key
EG002
source section id
NCT02178722-ae
event group key
EG002
event group label
Phase 1: Epacadostat 100 MG BID
serious affected
9
serious at risk
18
other affected
17
other at risk
18
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
harm key
EG003
source section id
NCT02178722-ae
event group key
EG003
event group label
Phase 1: Epacadostat 300 MG BID
serious affected
9
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
harm key
EG004
source section id
NCT02178722-ae
event group key
EG004
event group label
Phase 2: Epacadostat 100 MG BID
serious affected
195
serious at risk
382
other affected
375
other at risk
382
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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-gastric-cancer
nct id
NCT02178722
harm key
EG005
source section id
NCT02178722-ae
event group key
EG005
event group label
Total
serious affected
221
serious at risk
444
other affected
434
other at risk
444
frequency threshold
5
collection period
Approximately 54 months
event definition
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
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