Clinical Trials

Numerous clinical trials evaluate Epacadostat across a broad spectrum of oncology indications, including unresectable or metastatic solid tumors, melanoma, non-small-cell lung carcinoma, endometrial cancer, and ovarian malignancies. Spanning Early Phase 1 through Phase 3, these combination and monotherapy studies are sponsored by major pharmaceutical developers such as Incyte Corporation and Merck Sharp & Dohme LLC, alongside academic research institutions including Memorial Sloan Kettering Cancer Center and City of Hope Medical Center. Across these investigations, protocol recruitment statuses encompass completed, active, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07490002 NOT_YET_RECRUITING
Esophageal Squamous Carcinoma
Changhai Hospital
 2026-04-06 PHASE2
NCT03516708 RECRUITING
Rectal Cancer
Washington University School of Medicine
 2020-01-06 PHASE1; PHASE2
NCT04463771 COMPLETED
Endometrial Cancer
Incyte Corporation
 2021-01-26 PHASE2
NCT03493945 COMPLETED
Metastatic Castration-resistant Prostate Cancer; Prostate Cancer; Prostate Neoplasm; Advanced Solid Tumor; Solid Tumor; Non-metastatic Castration-resistant Prostate Cancer
National Cancer Institute (NCI)
 2018-05-01 PHASE1; PHASE2
NCT03414229 ACTIVE_NOT_RECRUITING
Sarcoma
Memorial Sloan Kettering Cancer Center
 2018-01-23 PHASE2
NCT03532295 COMPLETED
Glioma; Glioblastoma
Washington University School of Medicine
 2020-04-20 PHASE2
NCT03217669 UNKNOWN
Advanced Solid Tumor; Non-small Cell Lung Cancer (NSCLC)
Chao Huang
 2018-02-22 PHASE1
NCT04586244 TERMINATED
Urothelial Carcinoma
Incyte Corporation
 2022-01-14 PHASE2
NCT03006302 COMPLETED
Metastatic Pancreatic Adenocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2018-01-31 PHASE2
NCT03589651 COMPLETED
Unresectable or Metastatic Solid Tumors
Incyte Corporation
 2018-08-17 PHASE1
NCT03823131 TERMINATED
Metastatic Head and Neck Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Unresectable Head and Neck Squamous Cell Carcinoma
Chase Heaton, MD
 2019-05-02 PHASE2
NCT04231864 WITHDRAWN
Epstein-Barr Virus Positive; Metastatic Nasopharyngeal Carcinoma; Recurrent Nasopharyngeal Carcinoma; Stage III Nasopharyngeal Carcinoma; Stage IV Nasopharyngeal Carcinoma; Stage IVA Nasopharyngeal Carcinoma; Stage IVB Nasopharyngeal Carcinoma
Alain Algazi
 2020-12-01 PHASE2
NCT03471286 TERMINATED
Solid Tumor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2019-06-06 PHASE1
NCT03602586 COMPLETED
Malignant Ovarian Clear Cell Tumor; Recurrent Ovarian Carcinoma
National Cancer Institute (NCI)
 2018-12-21 PHASE2
NCT03347123 TERMINATED
Solid Tumors
Incyte Corporation
 2018-03-21 PHASE1; PHASE2
NCT03238638 WITHDRAWN
Head and Neck Cancer
University of Chicago
 2018-09 PHASE2
NCT02862457 COMPLETED
Neoplasms; Carcinoma, Non-Small-Cell Lung
Merck Sharp & Dohme LLC
 2016-08-23 PHASE1
NCT02785250 UNKNOWN
Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Peritoneal Cancer
ImmunoVaccine Technologies, Inc. (IMV Inc.)
 2016-04 PHASE1; PHASE2
NCT02166905 COMPLETED
Fallopian Tube Carcinoma; Ovarian Carcinoma; Primary Peritoneal Carcinoma
Roswell Park Cancer Institute
 2014-10-10 PHASE1; PHASE2
NCT03291054 TERMINATED
Gastrointestinal Stromal Tumors
Columbia University
 2018-02-28 PHASE2
NCT03277352 TERMINATED
Advanced Malignancies; Metastatic Cancer
Incyte Biosciences International Sàrl
 2017-11-21 PHASE1; PHASE2
NCT02327078 COMPLETED
B-cell Malignancies; Colorectal Cancer (CRC); Head and Neck Cancer; Lung Cancer; Lymphoma; Melanoma; Ovarian Cancer; Glioblastoma
Incyte Corporation
 2014-11-26 PHASE1; PHASE2
NCT03432676 WITHDRAWN
ATM Gene Mutation; Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Homologous Recombination Deficiency; Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
M.D. Anderson Cancer Center
 2019-07-31 PHASE2
NCT03592407 WITHDRAWN
Esophageal Squamous Cell Carcinoma; Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
City of Hope Medical Center
 2018-07-01 PHASE2
NCT03322384 COMPLETED
Advanced Solid Tumors; Lymphoma
University of California, Davis
 2018-01-17 PHASE1; PHASE2
NCT03707457 TERMINATED
Glioblastoma; Glioblastoma Multiforme
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2019-03-22 PHASE1
NCT03491579 WITHDRAWN
AML; Relapse
Insel Gruppe AG, University Hospital Bern
 2018-12 PHASE1
NCT02318277 COMPLETED
Solid Tumors; Head and Neck Cancer; Lung Cancer; UC (Urothelial Cancer)
Incyte Corporation
 2015-01-05 PHASE1; PHASE2
NCT03444649 WITHDRAWN
AML
Insel Gruppe AG, University Hospital Bern
 2018-09 PHASE1
NCT03182894 WITHDRAWN
Metastatic Colorectal Cancer
James J Lee
 2018-09-30 PHASE1; PHASE2
NCT02364076 UNKNOWN
Thymic Carcinoma; Thymus Neoplasms; Thymus Cancer
Georgetown University
 2015-03 PHASE2
NCT03832673 WITHDRAWN
Muscle-invasive Bladder Cancer
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2019-05-22 PHASE2
NCT03361228 TERMINATED
Solid Tumors
Incyte Corporation
 2018-03-01 PHASE1; PHASE2
NCT02959437 TERMINATED
Solid Tumors; Advanced Malignancies; Metastatic Cancer
Incyte Corporation
 2017-02-27 PHASE1; PHASE2
NCT03085914 COMPLETED
Solid Tumor
Incyte Corporation
 2017-05-02 PHASE1; PHASE2
NCT03322540 COMPLETED
Lung Cancer
Incyte Corporation
 2017-12-15 PHASE2
NCT03322566 COMPLETED
Lung Cancer
Incyte Corporation
 2018-01-09 PHASE2
NCT03463161 TERMINATED
Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer
University of Chicago
 2018-03-23 PHASE2
NCT02178722 COMPLETED
Microsatellite-instability (MSI) High Colorectal Cancer (CRC); Endometrial Cancer; Head and Neck Cancer; Hepatocellular Carcinoma (HCC); Gastric Cancer; Lung Cancer; Lymphoma; Renal Cell Carcinoma (RCC); Ovarian Cancer; Solid Tumors; UC (Urothelial Cancer); Melanoma; Bladder Cancer; Triple Negative Breast Cancer (TNBC)
Incyte Corporation
 2014-07-17 PHASE1; PHASE2
NCT03325465 WITHDRAWN
Squamous Cell Carcinoma of the Head and Neck
University of Chicago
 2018-01-22 PHASE2
NCT03402880 WITHDRAWN
Extensive Stage Small Cell Lung Carcinoma
City of Hope Medical Center
 2018-10 PHASE2
NCT02559492 TERMINATED
Solid Tumors
Incyte Corporation
 2015-11 PHASE1
NCT03310567 WITHDRAWN
Recurrent/ Metastatic Endometrial Carcinoma
Fox Chase Cancer Center
 2018-09 PHASE2
NCT03260894 COMPLETED
Renal Cell Carcinoma (RCC)
Incyte Corporation
 2017-12-07 PHASE3
NCT03361865 COMPLETED
UC (Urothelial Cancer)
Incyte Corporation
 2017-12-04 PHASE3
NCT03589651 Completed
Unresectable or Metastatic Solid Tumors
Incyte Corporation
 2018-08-17 Phase 1
NCT03374488 COMPLETED
UC (Urothelial Cancer)
Incyte Corporation
 2017-12-22 PHASE3
NCT03358472 COMPLETED
Head and Neck Cancer
Incyte Corporation
 2017-12-01 PHASE3
NCT03196232 COMPLETED
Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Stage IV Esophageal Cancer AJCC v7; Stage IV Gastric Cancer AJCC v7; Unresectable Esophageal Carcinoma
George Albert Fisher
 2017-09-13 PHASE2
NCT03348904 TERMINATED
Lung Cancer
Incyte Corporation
 2017-12-27 PHASE3
NCT02575807 TERMINATED
Platinum-resistant Ovarian Cancer; Platinum-resistant Fallopian Cancer; Platinum-resistant Peritoneal Cancer
Aduro Biotech, Inc.
 2016-03-08 PHASE1; PHASE2
NCT03342352 WITHDRAWN
Head and Neck Cancer
Incyte Corporation
 2017-12-15 PHASE3
NCT03361228 Terminated
Solid Tumors
Incyte Corporation
 2018-03-01 Phase 1|Phase 2
NCT02752074 COMPLETED
Melanoma
Incyte Corporation
 2016-06-21 PHASE3
NCT02298153 TERMINATED
NSCLC (Non-small Cell Lung Carcinoma); UC (Urothelial Cancer)
Incyte Corporation
 2015-01-27 PHASE1
NCT01982487 WITHDRAWN
Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IA Fallopian Tube Cancer; Stage IA Ovarian Epithelial Cancer; Stage IA Primary Peritoneal Cavity Cancer; Stage IB Fallopian Tube Cancer; Stage IB Ovarian Epithelial Cancer; Stage IB Primary Peritoneal Cavity Cancer; Stage IC Fallopian Tube Cancer; Stage IC Ovarian Epithelial Cancer; Stage IC Primary Peritoneal Cavity Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Epithelial Cancer; Stage IIA Primary Peritoneal Cavity Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IIB Primary Peritoneal Cavity Cancer; Stage IIC Fallopian Tube Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IIC Primary Peritoneal Cavity Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer
Roswell Park Cancer Institute
 2013-12 PHASE1; PHASE2
NCT01604889 TERMINATED
Melanoma
Incyte Corporation
 2012-03-29 PHASE1; PHASE2
NCT02042430 COMPLETED
Stage III Fallopian Tube Cancer AJCC v7; Stage III Ovarian Cancer AJCC v6 and v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7
National Cancer Institute (NCI)
 2014-08-25 EARLY_PHASE1
NCT01961115 COMPLETED
Mucosal Melanoma; Recurrent Melanoma; Recurrent Uveal Melanoma; Stage IIIA Skin Melanoma; Stage IIIA Uveal Melanoma; Stage IIIB Skin Melanoma; Stage IIIB Uveal Melanoma; Stage IIIC Skin Melanoma; Stage IIIC Uveal Melanoma; Stage IV Skin Melanoma; Stage IV Uveal Melanoma
Fred Hutchinson Cancer Center
 2013-09-13 PHASE2
NCT02118285 COMPLETED
Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma
Masonic Cancer Center, University of Minnesota
 2014-07-28 PHASE1
NCT01822691 COMPLETED
Myelodysplastic Syndromes
H. Lee Moffitt Cancer Center and Research Institute
 2013-07 PHASE2
NCT01685255 TERMINATED
Ovarian Cancer; Genitourinary (GU) Tumors
Incyte Corporation
 2012-08 PHASE2
NCT01195311 COMPLETED
Solid Tumors and Hematologic Malignancy
Incyte Corporation
 2010-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-24)

Check the Epacadostat (INCB024360) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Epacadostat (INCB024360) selectively binds to and inhibits indoleamine 2,3-dioxygenase 1 (IDO1), blocking the metabolic conversion of tryptophan into kynurenine and preventing downstream immunosuppressive signaling. By reversing immune tolerance and restoring cytotoxic effector T-cell function within the tumor microenvironment, this enzyme inhibition promotes antitumor immunity in clinical trial indications including melanoma, non-small-cell lung cancer, and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.