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Epacadostat

Phase 2

Sarcoma | Small molecule | Oncology |Incyte Corporation|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03414229A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced SarcomaPHASE2 ACTIVE NOT_RECRUITING 30Jan 23, 2018Jan 1, 2027Apr 23, 20261 United States
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Study Endpoints
Primary Endpoints
Number of Patients With Best Objective Response Rate
by 24 weeks

by RECIST 1.1.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UPS, Liposarcoma or pleomorphic liposarcomaEXPERIMENTALUndifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
LeiomyosarcomaEXPERIMENTALEpacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Vascular Sarcoma SubtypesEXPERIMENTALIncluding angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
OtherEXPERIMENTALEpacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Interventions
NameTypeDescription
EpacadostatDRUG100mg bid days 1-21
PembrolizumabDRUG200mg/dose Day 1, Q 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female age ≥ 18 years at the time of informed consent * Be willing and able to provide written informed consent/assent for the trial * Be willing to comply with treatment protocol * Subjects must have a histologically confirmed metastatic and/or locally advanced sarcom...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT03414229primaryCompletionDate: changed
LOWMay 24, 2026NCT03414229studyFirstPostDate: changed