Table 4.
Ongoing phase II/III trial evaluating IDO inhibitor or tryptophan mimetic agents in monotherapy or in combination strategy with others drugs.
| Study title | Study number | Condition or disease | Treatments | Status—phase |
|---|---|---|---|---|
| A phase 2 study of the IDO inhibitor epacadostat vs. tamoxifen for subjects with biochemical-recurrent-only EOC, PPC or FTC following complete remission with first-line chemotherapy | NCT01685255 | Ovarian cancer Genitourinary (GU) tumors | Epacadostat Tamoxifen | Terminated—phase 2 |
| A phase II double-blinded, randomized, placebo-controlled study of indoximod in combination with a taxane chemotherapy in metastatic breast cancer | NCT01792050 | Metastatic breast cancer | Docetaxel or paclitaxel Indoximod | Accrual completed—phase 2 |
| A phase II trial of IDO-inhibitor, BMS-986205, and PD-1 inhibitor, nivolumab, in patients with recurrent or persistent endometrial cancer or endometrial carcinosarcomas (CA017-056) | NCT04106414 | Endometrial adenocarcinoma Endometrial carcinosarcoma | Nivolumab BMS-986205 | Recruiting—phase 2 |
| A phase 1/2 study of the concomitant administration of indoximod plus immune checkpoint inhibitors for adult patients with advanced or metastatic melanoma | NCT02073123 | Metastatic melanoma Stage III melanoma Stage IV melanoma | Indoximod Ipilimumab Nivolumab Pembrolizumab | Recruiting—phase 1/2 |
| A phase I/II study of the combination of indoximod and temozolomide for adult patients with temozolomide-refractory primary malignant brain tumors | NCT02052648 | Glioblastoma multiforme Glioma Gliosarcoma Malignant brain tumor | Indoximod + temozolomide Temozolomide Bevacizumab Stereotactic radiation | Completed—phase 1/2 |
| A phase I/II study of indoximod in combination with gemcitabine and Nab-paclitaxel in patients with metastatic adenocarcinoma of the pancreas | NCT02077881 | Metastatic pancreatic adenocarcinoma Metastatic pancreatic cancer | Nab-paclitaxel Gemcitabine Indoximod | Completed—phase 1–2 |
| A phase II study of epacadostat and pembrolizumab in patients with imatinib refractory advanced gastrointestinal stromal tumors | NCT03291054 | Gastrointestinal stromal tumors | Pembrolizumab Epacadostat | Recruiting—phase 2 |
| A phase I/IIb study of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) given with adjuvant poly-ICLC in combination with INCB024360 for patients in remission with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express NY-ESO-1 or LAGE-1 antigen | NCT02166905 | Fallopian tube carcinoma Ovarian carcinoma Primary peritoneal carcinoma | Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401 Epacadostat | Recruiting—phase 1/2 |
| Phase I/II trial of BMS-986205 and nivolumab as first or second-line therapy in hepatocellular carcinoma | NCT03695250 | Metastatic hepatocellular carcinoma Stage III hepatocellular carcinoma AJCC v8 Stage IIIA hepatocellular carcinoma AJCC v8 | IDO1 inhibitor BMS-986205 Nivolumab | Recruiting—phase 1/2 |
| A phase II study to determine the safety and efficacy of INCB024360 in patients with myelodysplastic syndromes | NCT01822691 | Myelodysplastic syndromes | INCB024360 | Terminated—phase 2 |
| Influence of the celecoxib administration before surgery for endometrial cancer on indoleamine 2,3-dioxygenase 1 (IDO1) tumor expression and immune cells tumor's infiltration | NCT03896113 | Endometrium cancer | Drug: celecoxib 200-mg capsule | Recruiting—phase 2 |
| Window-of-opportunity trial of nivolumab and BMS986205 in patients with squamous cell carcinoma of the head and neck (CA017-087) | NCT03854032 | Lip Oral cavity squamous cell carcinoma Pharynx Larynx squamous cell carcinoma | Nivolumab IDO1 inhibitor BMS-986205 | Recruiting—phase 2 |
| Phase II study of epacadostat (INCB024360) in combination with pembrolizumab in patients with locally advanced/metastatic sarcoma | NCT03414229 | Locally advanced/Metastatic sarcoma | Epacadostat Pembrolizumab | Active not recruiting—phase 2 |
| A phase II pilot trial of an indoleamine 2,3, dioxygenase-1 (IDO1) inhibitor (INCB024360) plus a multipeptide melanoma vaccine (MELITAC 12.1) in patients with advanced melanoma | NCT01961115 | Advanced/metastatic melanoma (mucosal, uveal, skin) | Epacadostat MELITAC 12.1 peptide vaccine | Completed—phase 2 |
| A phase 1/2, open-label, safety, tolerability, and efficacy study of epacadostat in combination with pembrolizumab and chemotherapy in subjects with advanced or metastatic solid tumors (ECHO-207/KEYNOTE-723) | NCT03085914 | Solid tumors Colorectal cancer (CRC) Adenocarcinoma (PDAC) Lung cancer UC (urothelial cancer) Head and neck cancer | Epacadostat Pembrolizumab Oxaliplatin 5-Fluorouracil Gemcitabine Nab-paclitaxel Carboplatin Paclitaxel Pemetrexed Cyclophosphamide Cisplatin | Active not recruiting—phase 1–2 |
| A phase 1/2, open-label, dose-escalation, safety, tolerability, and efficacy study of epacadostat and nivolumab in combination with immune therapies in subjects with advanced or metastatic malignancies (ECHO-208) | NCT03347123 | Solid tumors | Epacadostat Nivolumab Ipilimumab Lirilumab | Active not recruiting—phase 1–2 |
| A phase 1/2 study of relatlimab (anti-LAG-3 monoclonal antibody) administered in combination with both nivolumab (anti-PD-1 monoclonal antibody) and BMS-986205 (IDO1 inhibitor) or in combination with both nivolumab and ipilimumab (anti-CTLA-4 monoclonal antibody) in advanced malignant tumors | NCT03459222 | Advanced cancer | Relatlimab Nivolumab BMS-986205 Ipilimumab | Recruiting—phase 1–2 |