Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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 (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.

Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported.

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secondary · POSTED

The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.

Safety Population

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secondary · POSTED

INCB001158 was dosed orally BID.

Safety Population

→

secondary · POSTED

ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.

Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.

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secondary · POSTED

BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.

REEP. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.

→

secondary · POSTED

DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.

REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.

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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-lung-carcinoma-bizengri-9004587b
nct id: NCT02903914
trial label: Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
source section id
NCT02903914-om-0000
source outcome index
0
endpoint
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
endpoint definition
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.
time origin
up to study completion (up to approximately 3.5 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported.
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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0001
source section id
NCT02903914-om-0001
source outcome index
1
endpoint
Recommended Phase 2 Dose (RP2D) of INCB001158
endpoint definition
The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.
time origin
12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population
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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0002
source section id
NCT02903914-om-0002
source outcome index
2
endpoint
RP2D of INCB001158 in Combination With Pembrolizumab
endpoint definition
INCB001158 was dosed orally BID.
time origin
12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population
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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0003
source section id
NCT02903914-om-0003
source outcome index
3
endpoint
Objective Response Rate (ORR)
endpoint definition
ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.
time origin
Until disease progression/study discontinuation (up to approximately 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0004
source section id
NCT02903914-om-0004
source outcome index
4
endpoint
Percentage of Participants With the Indicated Best Overall Response (BOR)
endpoint definition
BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.
time origin
Until disease progression/study discontinuation (up to approximately 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
REEP. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0005
source section id
NCT02903914-om-0005
source outcome index
5
endpoint
Duration of Response (DOR)
endpoint definition
DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.
time origin
Until disease progression/study discontinuation (up to approximately 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG000
arm label
Part 1A: INCB001158 50 mg
regimen
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG001
arm label
Part 1A: INCB001158 75 mg
regimen
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG002
arm label
Part 1A: INCB001158 100 mg
regimen
INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG003
arm label
Part 1A: INCB001158 150 mg
regimen
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG004
arm label
Part 1B: INCB001158 50 mg + Pembrolizumab
regimen
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG005
arm label
Part 1B: INCB001158 75 mg + Pembrolizumab
regimen
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG006
arm label
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
regimen
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
analyzed count
123
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0000
arm key
OG007
arm label
Part 1C: INCB001158 50 mg + Pembrolizumab
regimen
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0001
arm key
OG000
arm label
INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID
regimen
Monotherapy Part 1a: INCB001158 was administered orally in participants with advanced/metastatic solid tumors. Sequential dose escalation of single-agent INCB001158 took place in participants with advanced/metastatic solid tumors.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0002
arm key
OG000
arm label
INCB001158 as Combination Therapy at 50, 75, and 100 mg BID
regimen
INCB001158 administered orally in patients at 50, 75, and 100 mg doses BID with advanced/metastatic solid tumors in combination with pembrolizumab (200 mg IV Q3W)
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0003
arm key
OG000
arm label
Part 1A: INCB001158 50 mg
regimen
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
outcome key
om-0003
arm key
OG001
arm label
Part 1A: INCB001158 75 mg
regimen
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02903914-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG000
source section id
NCT02903914-ae
event group key
EG000
event group label
Part 1A: INCB001158 50 mg
serious affected
3
serious at risk
8
other affected
7
other at risk
8
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG001
source section id
NCT02903914-ae
event group key
EG001
event group label
Part 1A: INCB001158 75 mg
serious affected
2
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG002
source section id
NCT02903914-ae
event group key
EG002
event group label
Part 1A and Part 2: INCB001158 100 mg
serious affected
31
serious at risk
85
other affected
77
other at risk
85
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG003
source section id
NCT02903914-ae
event group key
EG003
event group label
Part 1A: INCB001158 150 mg
serious affected
0
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG004
source section id
NCT02903914-ae
event group key
EG004
event group label
Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab
serious affected
6
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG005
source section id
NCT02903914-ae
event group key
EG005
event group label
Part 1B: INCB001158 75 mg + Pembrolizumab
serious affected
5
serious at risk
14
other affected
13
other at risk
14
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG006
source section id
NCT02903914-ae
event group key
EG006
event group label
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
serious affected
47
serious at risk
123
other affected
116
other at risk
123
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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-lung-carcinoma-bizengri-9004587b
nct id
NCT02903914
harm key
EG007
source section id
NCT02903914-ae
event group key
EG007
event group label
Total
serious affected
94
serious at risk
260
other affected
243
other at risk
260
frequency threshold
5
collection period
up to approximately 3.5 years
event definition
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + 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