Trial · NCT02903914
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
NCT02903914, Phase 1, Completed, Incyte Corporation; results first posted 2021-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors. Trials, record NCT02903914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02903914
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
- NCT number
- NCT02903914
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 260 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer, Head and Neck Cancer, Lung Cancer, Renal Cell Carcinoma (RCC), Bladder Cancer, UC (Urothelial Cancer), Mesothelioma
- Interventions
- INCB001158, Pembrolizumab
- First posted
- 2016-09-16
- Last updated
- 2025-08-05
- Other registries' IDs
- eudract:2017-002903-82
- Results first posted
- 2021-09-30
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to study completion (up to approximately 3.5 years) | 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. |
| Secondary | Recommended Phase 2 Dose (RP2D) of INCB001158 | 12 weeks | 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. |
| Secondary | RP2D of INCB001158 in Combination With Pembrolizumab | 12 weeks | INCB001158 was dosed orally BID. |
| Secondary | Objective Response Rate (ORR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. |
| Secondary | Percentage of Participants With the Indicated Best Overall Response (BOR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. |
| Secondary | Duration of Response (DOR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. |
| Secondary | Progression-free Survival (PFS) | Until disease progression/study discontinuation (up to approximately 5 years) | PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. 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. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. |
| Secondary | Cmax of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | Cmax was defined as the maximum observed concentration of INCB001158. |
| Secondary | Tmax of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | tmax was defined as the time of the maximum observed concentration of INCB001158. |
| Secondary | AUC0-t of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-t was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to time t. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to study completion (up to approximately 3.5 years) | Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Recommended Phase 2 Dose (RP2D) of INCB001158 | 12 weeks | Safety Population | milligrams | NUMBER |
| SECONDARY | RP2D of INCB001158 in Combination With Pembrolizumab | 12 weeks | Safety Population | milligrams | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Indicated Best Overall Response (BOR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Until disease progression/study discontinuation (up to approximately 5 years) | 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. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Until disease progression/study discontinuation (up to approximately 5 years) | PFS Efficacy Evaluable Population (Full Analysis Set): all participants who received at least 1 dose of INCB001158 or pembrolizumab. One participant was to be treated with INCB001158 100 mg + pembrolizumab but actually received INCB001158 75 mg + pembrolizumab. For PFS analysis, this participant was analyzed in their planned treatment group (INCB001158 100 mg + pembrolizumab) rather than in the actual treatment group. | months | MEDIAN |
| SECONDARY | Cmax of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | Pharmacokinetic (PK) Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab and contributed at least 1 PK sample | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population | hours | MEDIAN |
| SECONDARY | AUC0-t of INCB001158 Following Single Escalating Doses for Part 1A | Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | PK Population | hours x ng/mL | GEOMETRIC_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1A: INCB001158 50 mg | 7 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1A: INCB001158 75 mg | 7 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1A: INCB001158 100 mg | 81 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1A: INCB001158 150 mg | 7 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1B: INCB001158 50 mg + Pembrolizumab | 10 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1B: INCB001158 75 mg + Pembrolizumab | 13 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 123 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1C: INCB001158 50 mg + Pembrolizumab | 6 | Participants | ||
| Recommended Phase 2 Dose (RP2D) of INCB001158 | INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID | 100 | milligrams | ||
| RP2D of INCB001158 in Combination With Pembrolizumab | INCB001158 as Combination Therapy at 50, 75, and 100 mg BID | 100 | milligrams |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1A: INCB001158 50 mg | 8 | |
| Overall Study | STARTED | Part 1A: INCB001158 75 mg | 7 | |
| Overall Study | STARTED | Part 1A and Part 2: INCB001158 100 mg | 85 | |
| Overall Study | STARTED | Part 1A: INCB001158 150 mg | 7 | |
| Overall Study | STARTED | Part 1B: INCB001158 50 mg + Pembrolizumab | 10 | |
| Overall Study | STARTED | Part 1B: INCB001158 75 mg + Pembrolizumab | 14 | |
| Overall Study | STARTED | Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 123 | |
| Overall Study | STARTED | Part 1C: INCB001158 50 mg + Pembrolizumab | 6 | |
| Overall Study | COMPLETED | Part 1A: INCB001158 50 mg | 0 | |
| Overall Study | COMPLETED | Part 1A: INCB001158 75 mg | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,992
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1A: INCB001158 50 mg | 0 | 8 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1A: INCB001158 75 mg | 0 | 7 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1A and Part 2: INCB001158 100 mg | 0 | 85 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1A: INCB001158 150 mg | 0 | 7 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab | 0 | 16 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1B: INCB001158 75 mg + Pembrolizumab | 1 | 14 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 3 | 123 | 3 |
| other | Abdominal discomfort | Gastrointestinal disorders | Total | 4 | 260 | 4 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1A: INCB001158 50 mg | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1A: INCB001158 75 mg | 0 | 7 | 0 |
1 to 10 of 1,992Source ClinicalTrials.gov
See all 1,992 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1A: INCB001158 50 mg | 0 | 8 |
| Total, all-cause mortality | Part 1A: INCB001158 75 mg | 0 | 7 |
| Total, all-cause mortality | Part 1A and Part 2: INCB001158 100 mg | 12 | 85 |
| Total, all-cause mortality | Part 1A: INCB001158 150 mg | 0 | 7 |
| Total, all-cause mortality | Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab | 3 | 16 |
| Total, all-cause mortality | Part 1B: INCB001158 75 mg + Pembrolizumab | 3 | 14 |
| Total, all-cause mortality | Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 24 | 123 |
| Total, all-cause mortality | Total | 42 | 260 |
| Total, other adverse events | Part 1A: INCB001158 50 mg | 7 | 8 |
| Total, other adverse events | Part 1A: INCB001158 75 mg | 7 | 7 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02903914
GET https://conductscience.org/api/trials/v1/NCT02903914/registered?page=2