A Phase 1/2 interventional study of INCB001158 and Epacadostat in Solid Tumors, sponsored by Incyte Corporation. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Incyte Corporation · Phase 1/2, Interventional, and Treatment
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Among 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation — 1 open to participants now, 1 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Incyte Corporation.
Among the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, this one is the 26th largest by enrollment, is one of 5 that started in 2018, is one of 11 in phase 1/2, and was the 18th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →1 of the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation is open now, in 8 countries. Recruiting first, the newest first:
Incyte Corporation · Sites in United States, Australia, Belgium and 5 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 20 · Phase 3 3
First in 2014; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 53 across the 30 interventional studies. Of the 26 that completed or were terminated, 19 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
1 of the studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06179160Incyte CorporationA Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | 2027-01-01 |
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Among the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: INCB001158 · Drug: Epacadostat · Drug: Pembrolizumab
Drug: INCB001158 · Drug: Epacadostat
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Epacadostat at the protocol-defined dose administered orally twice daily.
Also known as: INCB024360
Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
Also known as: MK-3475
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Up to approximately 12 months per subject
Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to approximately 12 months per subject
Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Up to approximately 12 months per subject
Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
Time frame: Up to approximately 12 months per subject
Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
Time frame: Up to approximately 12 months per subject
Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Time frame: Up to approximately 12 months per subject
Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Time frame: Up to approximately 12 months per subject
Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat
Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
Time frame: Up to approximately 1 month
The study was conducted at 3 different sites in US. A total of 10 patients were screened and 5 patients enrolled in study.
| Milestone | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab |
|---|---|---|
| Started | 4 | 1 |
| Completed | 0 | 0 |
| Not completed | 4 | 1 |
| Withdrew: Other | 1 | 1 |
| Withdrew: Death | 3 | 0 |
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
No measurements were reported for this outcome.
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
No measurements were reported for this outcome.
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
No measurements were reported for this outcome.
Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
No measurements were reported for this outcome.
Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
No measurements were reported for this outcome.
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
No measurements were reported for this outcome.
Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
No measurements were reported for this outcome.
Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
No measurements were reported for this outcome.
Collected over up to approximately 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INCB001158 50mg BID+ Epacadostat + Pembrolizumab | 3/4 (75%) | 3/4 (75%) | 4/4 (100%) |
| INCB001158 75 mg BID + Epacadostat + Pembrolizumab | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Event | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab |
|---|---|---|
| AtaxiaNervous system disorders | 0/4 | 1/1 |
| Brain oedemaNervous system disorders | 0/4 | 1/1 |
| Myocardial infarctionCardiac disorders | 1/4 | 0/1 |
| Clostridium difficile infectionInfections and infestations | 1/4 | 0/1 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/4 | 0/1 |
| HydronephrosisRenal and urinary disorders | 1/4 | 0/1 |
| Event | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/4 | 0/1 |
| FatigueGeneral disorders | 2/4 | 0/1 |
| PyrexiaGeneral disorders | 2/4 | 0/1 |
| Dry eyeEye disorders | 1/4 | 0/1 |
| Abdominal pain lowerGastrointestinal disorders | 1/4 | 0/1 |
| Abdominal pain upperGastrointestinal disorders | 1/4 | 0/1 |
| ConstipationGastrointestinal disorders | 1/4 | 0/1 |
| Dry mouthGastrointestinal disorders | 1/4 | 0/1 |
| NauseaGastrointestinal disorders | 1/4 | 0/1 |
| VomitingGastrointestinal disorders | 1/4 | 0/1 |
No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
| Age, Continuous | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab | Total |
|---|
| Sex: Female, Male(participants) | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race/Ethnicity, Customized(participants) | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab | Total |
|---|
| Race/Ethnicity, Customized(participants) | INCB001158 50mg BID+ Epacadostat + Pembrolizumab | INCB001158 75 mg BID + Epacadostat + Pembrolizumab | Total |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Mar 2019, 12 months.
Results were first posted in May 2020, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CB-1158
Carcinoma, Non-Small-Cell Lung →