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NCT03516708 2026-02-11

Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer

Phase 1/2 Recruiting

Gastrointestinal

Rectal Neoplasms

NCT04463771 2025-12-10

POD1UM-204

Phase 2 Active not recruiting

Neoplasm Metastasis, Endometrial Neoplasms

NCT03358472 2025-12-03

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Phase 3 Completed

89 enrolled 14 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

NCT03532295 2025-11-21

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Phase 2 Completed

51 enrolled 16 charts

Glioblastoma, Glioma

NCT02959437 2025-10-21

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Phase 1/2 Terminated

70 enrolled 14 charts

Neoplasm Metastasis

NCT03493945 2025-09-30

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Phase 1/2 Completed

59 enrolled 20 charts

Prostatic Neoplasms

NCT02752074 2025-08-24

A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

Phase 3 Completed

706 enrolled 17 charts

Melanoma

NCT03322540 2025-08-22

Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

Phase 2 Completed

154 enrolled 14 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

NCT03361865 2025-08-22

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Phase 3 Completed

93 enrolled 13 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body

NCT03374488 2025-08-22

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Phase 3 Completed

84 enrolled 13 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Carcinoma, Transitional Cell

NCT02327078 2025-08-14

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Phase 1/2 Completed

307 enrolled 27 charts

CNSDermatologicGastrointestinalGynecologicHead & NeckLymphoidThoracic

Glioblastoma, Head and Neck Neoplasms, Lung Neoplasms, Lymphoma, Melanoma, Ovarian Neoplasms, Colorectal Neoplasms

NCT03260894 2025-07-29

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Phase 3 Completed

129 enrolled 13 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Carcinoma, Renal Cell

NCT03414229 2025-05-02

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Phase 2 Active not recruiting

30 enrolled 11 charts

Sarcoma

NCT02042430 2024-12-13

Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase EARLY_PHASE1 Completed

Fallopian Tube Neoplasms

NCT03006302 2024-10-08

Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

Phase 2 Completed

41 enrolled 14 charts

Gastrointestinal

Pancreatic Neoplasms

NCT03602586 2024-07-26

Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

Phase 2 Completed

14 enrolled 12 charts

Ovarian Neoplasms

NCT03291054 2024-06-11

Epacadostat and Pembrolizumab in Patients With GIST

Phase 2 Terminated

1 enrolled 1 chart

GastrointestinalSarcoma

Gastrointestinal Stromal Tumors

NCT03196232 2024-01-23

Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer

Phase 2 Completed

3 enrolled 12 charts

Gastrointestinal

Esophageal Neoplasms, Stomach Neoplasms

NCT03823131 2023-05-09

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

Phase 2 Terminated

14 enrolled 12 charts

Squamous Cell Carcinoma of Head and Neck

NCT03217669 2023-05-03

Epacadostat (INCB24360) in Combination With Sirolimus in Advanced Malignancy

Phase 1 Unknown

Carcinoma, Non-Small-Cell Lung

NCT02166905 2023-02-24

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

Phase 1/2 Completed

40 enrolled 15 charts

Fallopian Tube Neoplasms, Ovarian Neoplasms

NCT03589651 2023-02-21

INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Phase 1 Completed

Other solid neoplasm

Unresectable or Metastatic Solid Tumors

NCT03085914 2022-09-23

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

Phase 1/2 Completed

70 enrolled 17 charts

GastrointestinalThoracic

Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

NCT02862457 2022-08-19

MK-3475-434

Phase 1 Completed

34 enrolled 25 charts

Carcinoma, Non-Small-Cell Lung, Neoplasms

NCT03592407 2022-03-08

Epacadostat and Pembrolizumab Before Surgery in Treating Participants With Stage II-III Esophageal or Gastroesophageal Cancer

Phase 2 Withdrawn

Gastrointestinal

Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

NCT03347123 2022-02-28

A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)

Phase 1/2 Terminated

11 enrolled 12 charts

DermatologicHead & NeckThoracic

Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Melanoma

NCT02178722 2022-02-14

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Phase 1/2 Completed

444 enrolled 19 charts

BreastDermatologicGastrointestinalGenitourinaryGynecologicHead & NeckLymphoidThoracic

Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Head and Neck Neoplasms, Carcinoma, Hepatocellular, Lung Neoplasms, Lymphoma, Melanoma, Ovarian Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Microsatellite Instability, Triple Negative Breast Neoplasms

NCT03322384 2022-02-01

UCDCC#271: Phase I/II Trial of Epacadostat, Intralesional SD101, Radiotherapy in Patients With Lymphoma

Phase 1/2 Completed

20 enrolled 10 charts

Lymphoma

NCT03322566 2022-01-24

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Phase 2 Completed

233 enrolled 16 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

NCT02318277 2022-01-13

A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Phase 1/2 Completed

176 enrolled 25 charts

Head & NeckThoracic

Head and Neck Neoplasms, Lung Neoplasms

NCT03471286 2021-08-26

A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

Phase 1 Terminated

Other solid neoplasm

Solid Tumor

NCT03277352 2021-07-22

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1/2 Terminated

10 enrolled 14 charts

BreastDermatologicGastrointestinalGenitourinaryGynecologicHead & NeckOther solid neoplasmThoracic

Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Uterine Cervical Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Melanoma, Mesothelioma, Neoplasm Metastasis, Ovarian Neoplasms, Stomach Neoplasms, Carcinoma, Merkel Cell, Endometrial Neoplasms, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms

NCT02785250 2021-06-18

Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

Phase 1/2 Unknown

Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Neoplasms, Recurrence

NCT03832673 2021-02-26

PECULIAR

Phase 2 Withdrawn

Neoplasms

NCT03707457 2020-07-02

Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma

Phase 1 Terminated

Glioblastoma

NCT03361228 2020-05-21

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

Phase 1/2 Terminated

5 enrolled 4 charts

DermatologicGastrointestinalGenitourinaryHead & NeckThoracic

Parkinson Disease 4, Autosomal Dominant Lewy Body, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Melanoma, Colorectal Neoplasms, Small Cell Lung Carcinoma

NCT03463161 2020-01-27

ORKA

Phase 2 Terminated

2 enrolled 5 charts

Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

NCT03342352 2019-12-20

Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

Phase 3 Withdrawn

Parkinson Disease 4, Autosomal Dominant Lewy Body, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

NCT02364076 2019-12-13

Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

Phase 2 Unknown

45 enrolled 10 charts

Thymoma, Thymus Neoplasms

NCT02559492 2019-09-25

Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

Phase 1 Terminated

Other solid neoplasm

Solid Tumors

NCT03348904 2019-06-13

Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Phase 3 Terminated

2 enrolled 6 charts

Parkinson Disease 4, Autosomal Dominant Lewy Body, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

NCT03432676 2019-05-30

Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer

Phase 2 Withdrawn

Gastrointestinal

Pancreatic Neoplasms

NCT03325465 2019-04-22

Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck

Phase 2 Withdrawn

Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

NCT02575807 2019-04-04

SEASCAPE

Phase 1/2 Terminated

35 enrolled 20 charts

Ovarian Neoplasms

NCT01685255 2019-03-11

A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy

Phase 2 Terminated

Neoplasms, Ovarian Neoplasms

NCT03402880 2018-10-10

ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer

Phase 2 Withdrawn

Extensive Stage Small Cell Lung Carcinoma

NCT03182894 2018-08-28

Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer

Phase 1/2 Withdrawn

Gastrointestinal

Spinocerebellar Degenerations, Colorectal Neoplasms

NCT01961115 2018-06-08

Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma

Phase 2 Completed

11 enrolled 12 charts

Uveal Melanoma, Melanoma

NCT01195311 2018-01-17

A Dose-escalation Study in Subjects With Advanced Malignancies

Phase 1 Completed

Other hematologic neoplasm

Hematologic Neoplasms

NCT03238638 2018-01-04

A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Phase 2 Withdrawn

Head and Neck Neoplasms