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 · 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.
Exclusion Criteria:
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 |
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Incyte Biosciences International Sàrl