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Showing 1–17 of 17 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Indoximod Clear all
Completed Early Phase 1 Interventional Accepts healthy volunteers

Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers

NCT03852446
View directory record Official record
Conditions
Healthy
Interventions
Indoximod HCL (F2) tablets, Indoximod base formulation, Placebo
Drug · Other
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Secaucus, New Jersey
Source: ClinicalTrials.gov public record
Updated May 27, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

NCT02052648
View directory record Official record
Conditions
Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor
Interventions
Indoximod, Temozolomide, Bevacizumab, Stereotactic Radiation
Drug · Radiation
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
16 Years and older
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
17
States / cities
Castro Valley, California • Los Angeles, California • Orange, California + 14 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2024 · Synced Sep 2, 2026, 5:22 AM EDT
Active, not recruiting Phase 2 Interventional

Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG

NCT04049669
View directory record Official record
Conditions
Glioblastoma, Medulloblastoma, Ependymoma, Diffuse Intrinsic Pontine Glioma
Interventions
Indoximod, Partial Radiation, Full-dose Radiation, Temozolomide, Cyclophosphamide, Etoposide, Lomustine
Drug · Radiation
Lead sponsor
Theodore S. Johnson
Other
Eligibility
3 Years to 21 Years
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
5
States / cities
Augusta, Georgia • Druid Hills, Georgia • Boston, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Jan 7, 2026 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1 Interventional

1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors

NCT01191216
View directory record Official record
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
1-methyl-d-tryptophan, docetaxel, diagnostic laboratory biomarker analysis, pharmacological study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
5
States / cities
Tampa, Florida • Atlanta, Georgia • Billings, Montana + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2014 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer

NCT01042535
View directory record Official record
Conditions
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
adenovirus-p53 transduced dendritic cell (DC) vaccine, 1-methyl-d-tryptophan, Laboratory biomarker analysis
Biological · Drug · Other
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Apr 10, 2018 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 1 Interventional

IDO Inhibitor Study for Relapsed or Refractory Solid Tumors

NCT00739609
View directory record Official record
Conditions
Breast Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, Solid Tumors
Interventions
1-methyl-D-tryptophan
Drug
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated May 27, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 2 Interventional Results available

A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

NCT03301636
View directory record Official record
Conditions
Melanoma
Interventions
Pembrolizumab, Nivolumab, Indoximod
Drug
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
4
States / cities
Iowa City, Iowa • Rochester, Minnesota • Albuquerque, New Mexico + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 26, 2022 · Synced Sep 2, 2026, 5:22 AM EDT
Recruiting Phase 1 Interventional

Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer

NCT05106296
View directory record Official record
Conditions
Ependymoma, Medulloblastoma, Glioblastoma, Primary Brain Tumor
Interventions
Indoximod, Ibrutinib, Cyclophosphamide, Etoposide, Temozolomide
Drug
Lead sponsor
Theodore S. Johnson
Other
Eligibility
3 Years to 25 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jan 8, 2026 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1 Interventional

Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors

NCT02502708
View directory record Official record
Conditions
Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor, Ependymoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Primary CNS Tumor
Interventions
Indoximod, Temozolomide, Conformal Radiation, Cyclophosphamide, Etoposide
Drug · Radiation
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
3 Years to 21 Years
Enrollment
81 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
5
States / cities
Aurora, Colorado • Orlando, Florida • Atlanta, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

NCT02077881
View directory record Official record
Conditions
Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer
Interventions
Nab-Paclitaxel, Gemcitabine, Indoximod
Drug
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
157 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
11
States / cities
Palo Alto, California • Augusta, Georgia • Lexington, Kentucky + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 2, 2026 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 2 Interventional

Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer

NCT01792050
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Docetaxel, Placebo, Indoximod, Paclitaxel
Drug · Other
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
169 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
28
States / cities
Gainesville, Florida • Tampa, Florida • Titusville, Florida + 24 more
Source: ClinicalTrials.gov public record
Updated May 27, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Terminated Phase 1 Interventional

Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer

NCT02460367
View directory record Official record
Conditions
Non-small Cell Lung Cancer, Progression of Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Recurrent
Interventions
Docetaxel, Tergenpumatucel-L, Indoximod
Drug · Biological
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
2
States / cities
St Louis, Missouri • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 5, 2022 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 2 Interventional Results available

Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer

NCT01560923
View directory record Official record
Conditions
Metastatic Prostate Cancer
Interventions
Indoximod, Sipuleucel-T, Placebo
Biological · Other
Lead sponsor
Masonic Cancer Center, University of Minnesota
Other
Eligibility
18 Years and older · Male only
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
4
States / cities
Chicago, Illinois • Minneapolis, Minnesota • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 2, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Not yet recruiting Phase 1 Interventional

Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer

NCT07732413
View directory record Official record
Conditions
Progressive Pediatric Brain Cancer
Interventions
NLG802 (indoximod Prodrug), Temozolomide
Drug
Lead sponsor
Lumos Pharma
Industry
Eligibility
5 Years to 21 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1 Interventional

A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02835729
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Idarubicin, Cytarabine, Indoximod Freebase, Indoximod HCL F1, Indoximod HCL F2
Drug
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
2
States / cities
Augusta, Georgia • Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 3, 2020 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1 Interventional

1-Methyl-D-Tryptophan in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery

NCT00567931
View directory record Official record
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
1-methyl-d-tryptophan, pharmacological study, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
2
States / cities
Tampa, Florida • Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Jul 23, 2014 · Synced Sep 2, 2026, 5:22 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

NCT02073123
View directory record Official record
Conditions
Metastatic Melanoma, Stage III Melanoma, Stage IV Melanoma
Interventions
Indoximod, Ipilimumab, Nivolumab, Pembrolizumab
Drug
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
18 Years and older
Enrollment
131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
6
States / cities
Augusta, Georgia • Iowa City, Iowa • Rochester, Minnesota + 3 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Sep 2, 2026, 5:22 AM EDT