From: Targeting the IDO1 pathway in cancer: from bench to bedside
Drug | Strategies | Tumor type | Phase | Clinical efficacy | Safety (% patients) | Trial number | Status |
---|---|---|---|---|---|---|---|
Indoximod | Single agent | Metastatic or refractory solid tumors | I | NR | NR | NCT00739609 | Terminated |
Metastatic or refractory solid tumors | I | ORR 10% (5/48) | Fatigue (56.3%), anemia (37.5%), anorexia (37.5%) dyspnea (35.4%) cough (33.3%) nausea (29.2%) | NCT00567931 | Completed | ||
Docetaxel | Metastatic solid tumors | I | 4/22PRs, 9/22 SD, and 9/22 PD | Fatigue (58.6%) anemia (51.7%) hyperglycemia (48.3%), infection (44.8%), nausea (41.4%) | NCT01191216 | Completed | |
Temozolomide/bevacizumab | Primary malignant brain tumors | I/II | NR | NR | NCT02052648 | Recruiting | |
Temozolomide | Progressive primary malignant brain tumors | I | Â | Â | NCT02502708 | Recruiting | |
Docetaxel/paclitaxel | Metastatic breast cancer | II | Â | Â | NCT01792050 | Unknown | |
Nab-Paclitaxel/gemcitabine | Metastatic pancreatic cancer | I/II | ORR 11/30 (37%) | 1/30 (colitis) | NCT02077881 | Recruiting | |
Idarubicin/cytarabine | Acute myeloid leukemia | I/II | Â | Â | NCT02835729 | Recruiting | |
Adenovirus-p53 transduced dendritic cell (DC) vaccine | Metastatic breast cancer | I/II | Chemosensitization effect, median PFS 13.3 weeks and median OS 20.71 weeks. 9/22 patients benefitted from chemotherapy after vaccination. | Most common grade 1–2 (fatigue, anemia, transient lymphopenia, nausea, anorexia) | NCT01042535 | Completed | |
Sipuleucel-T | Refractory metastatic prostate cancer | II | NR | NR | NCT01560923 | Active, not recruiting | |
Tergenpumatucel-L/docetaxel | Advanced previously treated non-small cell lung cancer | I/II | Â | Â | NCT02460367 | Unknown | |
Ipilimumab/nivolumab/pembrolizumab | Metastatic melanoma | II/ III | Â | Â | NCT03301636 | Recruiting | |
Epacadostat | Single agent | Advanced malignancy | I/II | NR | Fatigue, nausea, decreased appetite, vomiting, constipation, abdominal pain, diarrhea, dyspnea, back pain, cough | NCT01195311 | Completed |
Solid tumor | I | Â | Â | NCT03471286 | Not yet recruiting | ||
Myelodysplastic syndromes | II | Â | Â | NCT01822691 | Completed | ||
Fludarabine/cyclophosphamide/NK cells/IL-2 | Recurrent ovarian, fallopian tube, and primary peritoneal cancer | I | Â | Â | NCT02118285 | Completed | |
Tamoxifen | Ovarian cancer genitourinary tumors | II | Median PFS, 3.75Â months | Fatigue (36.4%) rash (18.2%) pruritus (9.1%) | NCT01685255 | Terminated | |
Azacitidine + pembrolizumab | Advanced solid tumors | I/II | NR | NR | NCT02959437 | Recruiting | |
MELITAC 12.1 peptide vaccine | Stage III-IV melanoma | II | NR | NR | NCT01961115 | Active, not recruiting | |
DPX-survivac/cyclophosphamide | Ovarian cancer | I | NR | NR | NCT02785250 | Recruiting | |
ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine | Ovarian, fallopian tube, or primary peritoneal cancer | I/II | NR | NR | NCT01982487 | Withdrawn | |
DEC-205/NY-ESO-1 fusion protein CDX-1401/poly ICLC | Ovarian, fallopian tube, or primary peritoneal cancer | I/II | NR | NR | NCT02166905 | Recruiting | |
CRS-207/pembrolizumab | Metastatic pancreas cancer, platinum-resistant ovarian, fallopian, or peritoneal cancer | II,I/II | NR | NR | NCT03006302 | Recruiting active, not recruiting | |
NCT02575807 | |||||||
Atezolizumab | Non-small cell lung cancer and urothelial carcinoma | I | NR | NR | NCT02298153 | Terminated | |
Durvalumab | Advanced solid tumor | I/II | NR | NR | NCT02318277 | Recruiting | |
Ipilimumab | Melanoma | I/II | Â | Â | NCT01604889 | Terminated | |
Nivolumab/ipilimumab/lirilumab | Solid tumors | I/II | Â | Â | NCT03347123 | Recruiting | |
Nivolumab/chemotherapy | Advanced cancers | I/II | ORR 75%(melanoma) 11% (ovarian) 4% (colorectal) | Rash (10% and 12% in epacadostat 100 and 300Â mg subgroups) | NCT02327078 | Recruiting | |
Pembrolizumab/chemotherapy | Advanced solid tumors | I, I/II | NR | NR | NCT02862457 | Recruiting | |
NCT03085914 | Recruiting | ||||||
pembrolizumab | Solid tumors, thymic carcinoma, sarcoma, junction or gastric cancer, lung cancer, urothelial cancer, metastatic melanoma, and others. | I, I/II, III | Melanoma (ORR 57% and DCR 86%), Renal cell carcinoma (ORR 40% and DCR 80%) | Fatigue, diarrhea, rash, arthralgia, and nausea | NCT02178722 | Recruiting | |
NCT02364076 | Recruiting | ||||||
NCT03414229 | Recruiting | ||||||
NCT03196232 | Recruiting | ||||||
NCT03322540 | Recruiting | ||||||
NCT03361865 | Recruiting | ||||||
 | Pembrolizumab | Melanoma | III |  |  | NCT02752074 | Halted |
Navoximod | Single agent | Advanced solid tumors | I | NR | NR | NCT02048709 | Completed |
Atezolizumab | Solid tumors | I | Â | Â | NCT02471846 | Active, not recruiting | |
PF-06840003 | Single agent | Malignant gliomas | I | Â | Â | NCT02764151 | Active, not recruiting |
BMS-986205 | Nivolumab | Melanoma advanced cancers | III, I/II | NR | 3/42 patients with grade 3 autoimmune hepatitis | NCT03329846 | Recruiting |
NCT03192943 | Recruiting | ||||||
Nivolumab/ipilimumab | Advanced cancer melanoma non-small cell lung cancer | I/II | ORR 32%(bladder cancer) 14%(cervical cancer) PD-L1 > 1%: 46% (bladder cancer)and 25% (cervical cancer) | Fatigue (18.2% nausea (18.2%) decreased appetite (13.6%) vomiting (6.8%) | NCT02658890 | Recruiting | |
Nivolumab/ipilimumab/relatlimab | Advanced gastric cancer, advanced renal cell carcinoma, advanced cancer | II, I/II | NR | NR | NCT02935634 | Recruiting | |
NCT02996110 | Recruiting | ||||||
NCT03459222 | Not yet recruiting | ||||||
NCT03335540 | Recruiting | ||||||
Nivolumab/cetuximab/chemotherapy | Head and neck cancer | III | NR | NR | NCT03386838 | Halted | |
Nivolumab/chemotherapy | Lung cancer | III | Â | Â | NCT03417037 | Halted |