A Phase 1/2 interventional study of INCAGN01876 and Epacadostat in Advanced Malignancies and Metastatic Cancer, sponsored by Incyte Biosciences International Sàrl. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Incyte Biosciences International Sàrl (part of Incyte Corporation) · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Incyte Biosciences International Sàrl is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
First submitted after Incyte Biosciences International Sàrl became part of Incyte Corporation.
Counted across the registry records on this site, refreshed daily.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INCAGN01876 in combination with pembrolizumab and epacadostat
Drug: INCAGN01876 · Drug: Epacadostat · Drug: Pembrolizumab
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Epacadostat will be self-administered orally at the protocol-defined dose.
Also known as: INCB024360
Pembrolizumab will be administered IV at the protocol-defined dose.
Also known as: Keytruda®
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Screening through 60 days after end of treatment, up to approximately 18 months
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
Defined as time from first report of SD or better until disease progression or death from any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Overall Survival
Defined as the time from the start of combination therapy until death due to any cause.
Time frame: At 1 year and 2 years.
The study was conducted at 2 different sites in USA. A total of 10 participants were enrolled in the study.
| Milestone | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Started | 10 |
| Completed | 0 |
| Not completed | 10 |
| Withdrew: Study terminated by sponsor | 2 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Death | 4 |
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
| Participants | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 10 |
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
| Participants | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | 3 |
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
No measurements were reported for this outcome.
Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
| Participants | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | 7 |
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
| days | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | NA (273 to NA) |
Defined as time from first report of SD or better until disease progression or death from any cause.
| days | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| mRECIST | NA (525 to NA) |
| RECIST | 525 (92 to NA) |
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
| months | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| mRECIST | 17.36 (2.05 to NA) |
| RECIST | 4.20 (0.73 to NA) |
Defined as the time from the start of combination therapy until death due to any cause.
| months | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Phase 1 & Phase 2: Overall Survival | 25.59 (16.76 to NA) |
Collected over up to 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 4/10 (40%) | 3/10 (30%) | 10/10 (100%) |
| Total | 4/10 (40%) | 3/10 (30%) | 10/10 (100%) |
| Event | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | Total |
|---|---|---|
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/10 | 1/10 |
| ColitisGastrointestinal disorders | 1/10 | 1/10 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/10 | 1/10 |
| Rectal haemorrhageGastrointestinal disorders | 1/10 | 1/10 |
| UveitisEye disorders | 1/10 | 1/10 |
| Event | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | Total |
|---|---|---|
| FatigueGeneral disorders | 3/10 | 3/10 |
| Neck painMusculoskeletal and connective tissue disorders | 3/10 | 3/10 |
| PruritusSkin and subcutaneous tissue disorders | 3/10 | 3/10 |
| RashSkin and subcutaneous tissue disorders | 3/10 | 3/10 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/10 | 2/10 |
| ConstipationGastrointestinal disorders | 2/10 | 2/10 |
| Decreased appetiteMetabolism and nutrition disorders | 2/10 | 2/10 |
| HypomagnesaemiaMetabolism and nutrition disorders | 2/10 | 2/10 |
| Lipase increasedInvestigations | 2/10 | 2/10 |
| Rash generalisedSkin and subcutaneous tissue disorders | 2/10 | 2/10 |
The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
| Age, Continuous(years) | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Mean | 64.2 ± 13.73 |
| Sex: Female, Male(Participants) | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Female | 3 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Race/Ethnicity, Customized(Participants) | INCAGN01876 + Pembrolizumab + Epacadostat |
|---|---|
| White/Caucasian | 8 |
| Asian | 1 |
| Other | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ragifilimab
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