Table 1.
Ongoing and historical clinical trials that target IDO in cancer.
| Agent | Indication(s) | Phase | Status | Notes | NCT no. |
|---|---|---|---|---|---|
| Indoximod (D-1-MT) | Metastatic solid tumor | I | Completed | Combined with docetaxel | NCT01191216 |
| Solid tumor | I | Completed | Single agent | NCT00567931 | |
| Metastatic breast cancer | I/II | Active, not recruiting –> now completed | Combined with vaccine | NCT01042535 | |
| II | Recruiting | Combined with fulvestrant or tamoxifen and palbociclib | NCT02913430 | ||
| II | Active, not recruiting –> now completed | Combined with docetaxel or paclitaxel | NCT01792050 | ||
| Melanoma | I/II | Recruiting –> now active, not recruiting | Combined with ipilimumab (CTLA-4 mAb), nivolumab, or. pembrolizumab | NCT02073123 | |
| Metastatic Adenoma of Pancreas | I/II | Recruiting –> now completed | Combined with gemcitabine and nab-paclitaxel | NCT02077881 | |
| Acute myeloid leukemia | I/II | Recruiting | Combined with cytarbine, idarubicin | NCT02835729 | |
| GBM, glioma, gliosarcoma | I/II | Recruiting –> now active, not recruiting | Combined with temozolomide, bevacizumab (VEGF mAb) and radiation | NCT02052648 | |
| GBM, glioma, ependymoma, medulloblastoma | I | Recruiting | Combined with temozolomide and radiation or cyclophosphamide and etoposide | NCT02502708 | |
| Prostate carcinoma | II | Active, not recruiting–> now completed | Combined with sipuleucel-T | NCT01560923 | |
| NSCLC | II | Recruiting –> now active, not recruiting | Combined with docetaxel and tergenpumatucel-L | NCT02460367 | |
| INCB024360 | Advanced neoplasms | I | Completed | As single agent | NCT01195311 |
| Myelodysplastic Syndromes | II | Completed | As single agent | NCT01822691 | |
| Melanoma | I/II | Recruiting –> now terminated | Combined with ipilimumab | NCT01604889 | |
| II | Recruiting–> now completed | Combined with a multipeptide-based vaccine | NCT01961115 | ||
| Reproductive tract tumors | II | Completed –> now terminated | Compared to tamoxifen | NCT01685255 | |
| I/II | Recruiting | Combined with vaccine and cyclophosphamide | NCT02785250 | ||
| I | Active, not recruiting | With therapeutic conventional surgery | NCT02042430 | ||
| I | Recruiting–> now completed | Combined with adoptive transfer of NK cells, IL-2, fludarabine, and cyclophosphamide | NCT02118285 | ||
| I/II | Recruiting–> now terminated | Combined with CRS-207 and Pembrolizumab (PD-1 mAb) | NCT02575807 | ||
| I/II | Recruiting | Combined with DC-targeted NY-ESO-1 and poly-ICLC | NCT02166905 | ||
| I/II | Withdrawn | As single agent | NCT01982487 | ||
| II | Suspended | Combined with pembrolizumab | NCT03602586 | ||
| Solid tumors | I/II | Recruiting–> now active, not recruiting | Combined with MK-3475 | NCT02178722 | |
| I | Recruiting–> now active, not recruiting | Alone or combined with combination of pembrolizumab, cisplatin, pemetrexed, carboplatin, or paclitaxel | NCT02862457 | ||
| I | Active, not recruiting | Combined with itacitinib (JAK inhibitor) | NCT02559492 | ||
| I/II | Recruiting–> now active, not recruiting | Combined with combination of pembrolizumab, ozaliplatin, leucovorin, 5-fluorouracil, gemcitabine, nab-paclitaxel, carboplatin, paclitaxel, pemetrexed, cyclophasphamide, or cisplatin | NCT03085914 | ||
| I/II | Recruiting –> now completed | Combined with MEDI4736 (PD-L1 mAb) | NCT02318277 | ||
| I/II | Active, not recruiting | Combined with azacitidine, pembrolizumab | NCT02959437 | ||
| Meta. colorectal cancer | I/II | Not yet recruiting | Combined with pembrolizumab and azacitidine | NCT03182894 | |
| Gastric cancer | II | Not yet recruiting –> now recruiting | Combined with pembrolizumab | NCT03196232 | |
| Meta. Pancreatic cancer | II | Not yet recruiting –> now recruiting | Combined with CRS-207, pembrolizumab, CY, CRS-207, GVAX | NCT03006302 | |
| II | Withdrawn | Combined with pembrolizumab | NCT03432676 | ||
| *NSCLC, urothelial carcinoma | I | Active, not recruiting –> now terminated | Combined with atezolizumab (PD-L1 mAb) | NCT02298153 | |
| SCCHN | II | Withdrawn | Combined with pembrolizumab | NCT03325465 | |
| Head and neck cancer | III | Active, not recruiting | Combined with pembrolizumab vs. pembrolizumab alone or EXTREME regimen | NCT03358472 | |
| Lung cancer | II | Active, not recruiting | Combined with pembrolizumab, platinum-based chemotherapy | NCT03322566 | |
| II | Active, not recruiting | Combined with pembrolizumab | NCT03322540 | ||
| Renal cell carcinoma | III | Active, not recruiting | Combined with pembrolizumab vs. sunitinib and pazopanib | NCT03260894 | |
| Muscle invasive bladder cancer | II | Not yet recruiting | Combined with pembrolizumab | NCT03832673 | |
| Sarcoma | II | Recruiting | Combined with pembrolizumab | NCT03414229 | |
| GDC-0919 | Solid tumors | I | Completed | As single agent | NCT02048709 |
| (formerly NLG-919) | Locally-advanced or metastatic solid tumors | I | Active, not recruiting | Combined with MPDL3280A (PD-L1 mAb) | NCT02471846 |
| IDO1 peptide | NSCLC | I | Completed | As single agent | NCT01219348 |
| Melanoma | I | Recruiting –> now completed | Combined with ipilimumab or vemurafenib (BRAF inhibitor) | NCT02077114 | |
| II | Recruiting –> now terminated | Combined with temozolomide, imiquimod, GM-CSF, and survivin peptide | NCT01543464 | ||
| PF-06840003 | GBM or grade III anaplastic glioma | I | Recruiting –> now completed | As single agent | NCT02764151 |
| BMS986205 | Advanced cancer, melanoma, NSCLC | I/II | Recruiting | Combined with nivolumab and ipilimumab | NCT02658890 |
| Hepatocellular Carcinoma | I/II | Recruiting | Combined with nivolumab | NCT03695250 | |
| Lip, oral cavity squamous cell carcinoma, pharynx, larynx, squamous cell carcinoma | II | Recruiting | Combined with BMS-986205 | NCT03854032 | |
| Advanced cancer | I | Recruiting –> now completed | Combined with nivolumab | NCT03192943 | |
| DN1406131 | Advanced Solid Tumors | I | Not yet recruiting | As single agent | NCT03641794 |
| HTI-1090** | Advanced Solid Tumors | I | Active, not recruiting | As single agent | NCT03208959 |
| NLG802 | Solid tumor | I | Active, not recruiting | As single agent | NCT03164603 |
| SHR9146+SHR-1210 | Solid tumor, metastatic cancer, neoplasm malignant | I | Not yet recruiting | Combined with apatinib | NCT03491631 |
| MK-7162 | Solid Neoplasm | I | Recruiting | Combined with pembrolizumab | NCT03364049 |
*
NSCLC, non-small cell lung cancer; DLBCL, diffuse large B-cell lymphoma; SCCHN, squamous cell carcinoma of head/neck; UC, urothelial carcinoma.
**
IDO1-TDO dual enzymatic inhibitor.