20 completed, 14 terminated, 1 unknown, 1 withdrawn. 23 Phase 2, 20 Phase 1, 3 Phase 3, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 23 | Completed 12, Terminated 9, Unknown 1, Withdrawn 1 |
| Phase 1 | 20 | Completed 14, Terminated 6 |
| Phase 3 | 3 | Terminated 2, Completed 1 |
| Early Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers Indoximod HCL (F2) tablets, Indoximod base formulation, Placebo - Healthy | Early Phase 1 | Completed | NewLink Genetics Corporation | 56 | 2018-03-05 | 2020-05-28 |
| A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma Pembrolizumab, Nivolumab, Indoximod - Melanoma | Phase 2 | Terminated | NewLink Genetics Corporation | 21 | 2017-12-08 | 2022-09-27 |
| Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers Indoximod base formulation, Indoximod HCL (salt) formulation, Placebo - Healthy | Phase 1 | Completed | NewLink Genetics Corporation | 48 | 2017-11-21 | 2020-05-28 |
| Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy Pancreatic Cancer | Terminated | NewLink Genetics Corporation | 29 | 2017-09-01 | 2022-04-12 | |
| NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors NLG802 - Solid Tumor | Phase 1 | Completed | NewLink Genetics Corporation | 26 | 2017-06-29 | 2020-06-04 |
| A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Idarubicin, Cytarabine, Indoximod Freebase - Acute Myeloid Leukemia | Phase 1 | Completed | NewLink Genetics Corporation | 54 | 2016-07-01 | 2020-06-04 |
| Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer Docetaxel, Tergenpumatucel-L, Indoximod - Non-small Cell Lung Cancer, Progression of Non-small Cell Lung Cancer | Phase 1 | Terminated | NewLink Genetics Corporation | 16 | 2016-01-01 | 2022-04-06 |
| Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors CRLX101, Bevacizumab, mFOLFOX6 - Solid Tumors | Phase 1 | Terminated | NewLink Genetics Corporation | 41 | 2015-10-01 | 2020-05-28 |
| Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Indoximod, Temozolomide, Conformal Radiation - Glioblastoma Multiforme, Glioma | Phase 1 | Completed | NewLink Genetics Corporation | 81 | 2015-10-01 | 2020-06-04 |
| A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer CRLX101, Paclitaxel - Ovarian Cancer | Phase 1 / Phase 2 | Terminated | NewLink Genetics Corporation | 30 | 2015-07-01 | 2026-06-18 |
| Immunotherapy Study for Metastatic Renal Cell Cancer HyperAcute®-Renal (HAR) Immunotherapy - Metastatic Renal Cell Carcinoma, Metastatic Clear-cell Renal Cancer | Phase 1 | Completed | NewLink Genetics Corporation | 18 | 2015-05-01 | 2022-04-06 |
| Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors CRLX301 - Advanced Solid Tumor Malignancy | Phase 1 / Phase 2 | Terminated | NewLink Genetics Corporation | 42 | 2015-04-01 | 2020-06-09 |
| Immunotherapy and SBRT Study in Borderline Resectable Pancreatic Cancer mFOLFIRINOX, Algenpantucel-L Immunotherapy, SBRT - Pancreatic Cancer, Pancreatic Carcinoma Non-resectable | Phase 2 | Terminated | NewLink Genetics Corporation | 10 | 2015-04-01 | 2020-05-28 |
| Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine BPSC-1001 (VSVΔG-ZEBOV), Placebo - Ebola Viruses | Phase 1 | Completed | Dalhousie University | 40 | 2014-11-01 | 2016-02-09 |
| Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer Nab-Paclitaxel, Gemcitabine, Indoximod - Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer | Phase 1 / Phase 2 | Completed | NewLink Genetics Corporation | 157 | 2014-08-01 | 2026-04-03 |
| CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC) CRLX101, Bevacizumab, Standard of Care (Investigator Choice) - Metastatic Renal Cell Carcinoma | Phase 2 | Completed | NewLink Genetics Corporation | 115 | 2014-07-01 | 2020-05-28 |
| Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma Indoximod, Ipilimumab, Nivolumab - Metastatic Melanoma, Stage III Melanoma | Phase 1 / Phase 2 | Completed | NewLink Genetics Corporation | 131 | 2014-07-01 | 2026-05-29 |
| Immunotherapy Study for Patients With Stage IV Melanoma HyperAcute®-Melanoma (HAM) Immunotherapy, Ipilimumab, Pembrolizumab - Stage IV Melanoma, Metastatic Melanoma | Phase 2 | Terminated | NewLink Genetics Corporation | 47 | 2014-06-01 | 2023-04-18 |
| Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors Indoximod, Temozolomide, Bevacizumab - Glioblastoma Multiforme, Glioma | Phase 1 / Phase 2 | Completed | NewLink Genetics Corporation | 160 | 2014-03-01 | 2024-03-27 |
| Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer FOLFIRINOX, Algenpantucel-L Immunotherapy, 5-FU Chemoradiation - Pancreatic Cancer, Pancreatic Carcinoma Non-resectable | Phase 3 | Terminated | NewLink Genetics Corporation | 302 | 2013-05-01 | 2020-05-28 |
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Pancreatic Neoplasms (10) · Melanoma (7) · Carcinoma, Non-Small-Cell Lung (6) · Neoplasms (5) · Breast Neoplasms (4) · Lung Neoplasms (3) · Ovarian Neoplasms (3) · Recurrence (3) · Brain Neoplasms (2) · Carcinoma, Renal Cell (2) · Glioblastoma (2) · Glioma (2) · Gliosarcoma (2) · Neoplasm Metastasis (2) · Prostatic Neoplasms (2)
1-methyltryptophan (8) · IT-101 (6) · Gemcitabine (5) · Fluorouracil (4) · Paclitaxel (4) · Bevacizumab (3) · Docetaxel (3) · Leucovorin (3) · Nivolumab (3) · Oxaliplatin (3) · pembrolizumab (3) · 130-nm albumin-bound paclitaxel (2) · Albumin-Bound Paclitaxel (2) · Algenpantucel-L (2) · Immunotherapy (2)
United States (33) · Canada (1) · Poland (1) · Russia (1) · South Korea (1) · Ukraine (1)
Charles J. Link, M.D. (5) · Eugene Kennedy, MD (3) · Charles J. Link, Jr., M.D. (2) · Gene Kennedy, MD (2) · NewLink Genetics (2) · Adam I Riker, MD (1) · Arun Rajan, M.D. (1) · Elizabeth Dees, MD (1) · Franco Muggia, MD (1) · Glenn Weiss, M.D. (1) · Jeffrey D. Neidhart, M.D. (1) · Jonathan S Berek, MD, MMS (1) · Mary Mulcahy, M.D. (1) · NewLink Ge (1) · Ronald C. DeConti, M.D. (1)
PMID 23229886, PMID 20930628, PMID 28630358, PMID 28647166, PMID 28950297, PMID 32043778, PMID 33151286, PMID 33390325, PMID 33594602, PMID 33630475, PMID 37534996, PMID 37715730