From: Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy
Drug | Strategy | Tumor type | Phase | Clinical efficacy | Safety | Trial number | Status |
---|---|---|---|---|---|---|---|
Indoximod | Single agent | Healthy | Phase I | Unknown | Unknown | NCT03372239 | Completed |
Healthy | Early phase I | Unknown | Unknown | NCT03852446 | Completed | ||
Progressive brain tumors or newly diagnosed DIPG | Phase II | Unknown | Unknown | NCT04049669 | Recruiting | ||
Pembrolizumab/nivolumab | Advanced or metastatic melanoma | Phase I/II | Unknown | Unknown | NCT02073123 | Completed | |
Temozolomide | Refractory metastatic prostate cancer | Phase II | Stable disease (SD) 50% | Constipation, diarrhea, fatigue, pain, | NCT01560923 | Completed | |
Adenovirus-p53 transduced dendritic cell (DC) vaccine | Breast cancer | Not applicable | Unknown | Unknown | NCT01302821 | Withdrawn | |
Epacadostat | Single agent | Epithelial ovarian, fallopian tube or primary peritoneal carcinoma | Early phase I | Unknown | Unknown | NCT02042430 | Active, not recruiting |
Locally advanced rectal cancer | Phase I | Unknown | Unknown | NCT03516708 | Recruiting | ||
Pembrolizumab | Gastrointestinal stromal tumors | Phase II | Unknown | Unknown | NCT03291054 | Active, not recruiting | |
Head and neck cancer | Phase II | Unknown | Unknown | NCT03238638 | Withdrawn | ||
Squamous cell carcinoma of the head and neck | Phase II | Unknown | Unknown | NCT03325465 | Withdrawn | ||
Head and neck cancer patients, who failed prior PD-1/PD-L1 therapy | Phase II | Unknown | Unknown | NCT03463161 | Terminated | ||
Advanced pancreatic cancer | Phase II | Unknown | Unknown | NCT03432676 | Withdrawn | ||
Recurrent Clear cell carcinoma of the ovary | Phase II | Unknown | Unknown | NCT03602586 | Suspended | ||
Non-metastatic esophageal/gastroesophageal squamous cell and adenocarcinomas treated with neoadjuvant chemoradiation | Phase II | Unknown | Unknown | NCT03592407 | Withdrawn | ||
Recurrent/metastatic endometrial carcinoma | Phase II | Unknown | Unknown | NCT03310567 | Pembrolizumab | ||
Lung cancer | Phase II | Unknown | Unknown | NCT03322540 | Active, not recruiting | ||
Urothelial cancer (UC) | Phase III | Unknown | Unknown | NCT03374488 | Active, not recruiting | ||
Renal cell carcinoma (RCC) | Phase III | PR: 29.7%, CR + PR: 31.3%, [63] | Anaemia, diarrhoea, hypothyroidism, nausea, fatigue, pruritus | NCT03260894 | Recruiting | ||
Muscle-invasive bladder cancer | Phase II | Unknown | Unknown | NCT03832673 | Not yet recruiting | ||
Head and neck cancer | Phase III | Unknown | Hypothyroidism, vomiting, asthenia | NCT03358472 | Active, not recruiting | ||
Extensive stage small cell lung carcinoma | Phase II | Unknown | Unknown | NCT03402880 | Withdrawn | ||
Pembrolizumab/azacitidine | Metastatic colorectal cancer | Phase I/II | Unknown | Unknown | NCT03182894 | Withdrawn | |
Pembrolizumab/chemotherapy | Advanced solid tumors | Phase I | Unknown | Unknown | NCT02862457 | Active, not recruiting | |
Lung cancer | Phase II | Unknown | Nausea | NCT03322566 | Active, not recruiting | ||
INCB001158/pembrolizumab | Solid tumors | Phase I/II | Unknown | Unknown | NCT03361228 | Terminated | |
Electroporation/pembrolizumab | Squamous cell carcinoma of the head and neck | Phase II | Unknown | Unknown | NCT03823131 | Recruiting | |
Nivolumab/Ipilimumab | Advanced or metastatic malignancies | Phase I/II | Unknown | Unknown | NCT03347123 | Active, not recruiting | |
Nivolumab/chemotherapy | Lung cancer | Phase III | Unknown | Unknown | NCT03348904 | Terminated | |
Nivolumab/chemotherapy | Phase III | Unknown | Unknown | NCT03342352 | Withdrawn | ||
Durvalumab | Unresectable, recurrent, and metastatic EBV + NPC | Phase II | Unknown | Unknown | NCT04231864 | Not yet recruiting | |
Cladribine/cytarabine | Relapsed/refractory AML patients | Phase I | Unknown | Unknown | NCT03491579 | Withdrawn | |
Idarubicin/cytarabine/Daunorubicin | Phase 1 | Phase I | Unknown | Unknown | NCT03444649 | Withdrawn | |
Rapamycin | Advanced malignancy | Phase I | Unknown | Unknown | NCT03217669 | Recruiting | |
INCMGA00012 + RT + bevacizumab | Recurrent gliomas | Phase II | Unknown | Unknown | NCT03532295 | Recruiting | |
M7824 + BN-Brachyury + ALT-803 + Epacadostat (Immunotherapy) | Solid tumor | Phase I/II | Unknown | Unknown | NCT03493945 | Recruiting | |
INCMGA00012, Epacadostat 600 mg BID, SV-BR-1-GM combination | Metastatic or locally recurrent breast cancer patients | Phase I/II | Unknown | Unknown | NCT03328026 | Recruiting | |
Intralesional SD101, Radiotherapy | Advanced solid tumors lymphoma | Phase I/II | Unknown | Unknown | NCT03322384 | Recruiting | |
Itacitinib/INCB050465 | Solid tumors | Phase I | Unknown | Unknown | NCT02559492 | Terminated | |
BMS-986205 | Single agent | Healthy volunteers | Phase I | Unknown | Unknown | NCT03378310 | Completed |
NCT03374228 | |||||||
NCT03312426 | |||||||
NCT03362411 | |||||||
NCT03247283 | |||||||
Nivolumab | Advanced malignant solid tumors | Phase I/ II | Unknown | Unknown | NCT03792750 | Active, not recruiting | |
Recurrent or persistent endometrial carcinoma or endometrial carcinosarcoma | Phase II | Unknown | Unknown | NCT04106414 | Recruiting | ||
Squamous cell carcinoma of the head and neck | Phase II | Unknown | Unknown | NCT03854032 | Recruiting | ||
Resectable stage III or IV melanoma | Phase II | Unknown | Unknown | NCT04007588 | Withdrawn | ||
Relatlimab/nivolumab | Advanced malignant tumors | Phase I/ II | Unknown | Unknown | NCT03459222 | Recruiting | |
Nivolumab/BCG | BCG-unresponsive, high-risk, non-muscle invasive bladder cancer | Phase II | Unknown | Unknown | NCT03519256 | Recruiting | |
Itraconazole/rifampin | Malignancies multiple | Phase I | Unknown | Unknown | NCT03346837 | Completed | |
Nivolumab/chemotherapy | Muscle-invasive bladder cancer | Phase III | Unknown [64] | NCT03661320 | Recruiting | ||
Nivolumab/radiotherapy or chemoradiotherapy | Glioblastoma | Phase I | Unknown | Unknown | NCT04047706 | Recruiting | |
Omeprazole | Healthy | Phase I | Unknown | Unknown | NCT03936374 | Completed | |
Navoximod (GDC-0919, NLG-919) | Single agent | Recurrent advanced solid tumors | Phase I | 8 (36%) had stable disease and 10 (46%) had progressive disease [65, 66] | Fatigue (59%), cough, decreased appetite, and pruritus (41% each), nausea (36%), and vomiting (27%). Grade ≥ 3 AEs occurred in 14/22 patients (64%) | NCT02048709 | Completed |
PF-06840003 | Single agent | Malignant glioma | Phase I | Disease control occurred in eight patients (47%). Mean duration of stable disease (SD) was 32.1 (12.1–72.3) weeks [67, 68] | Grade 4 alanine and aspartate aminotransferase elevations | NCT02764151 | Terminated |
KHK2455 | Avelumab | Urothelial carcinoma | Phase I | Unknown | Unknown | NCT03915405 | Recruiting |
Mogamulizumab | Locally advanced or metastatic solid tumors | Phase I | Unknown | Unknown | NCT02867007 | Active, not recruiting | |
LY3381916 | Single agent or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054) | Solid tumor, non-small cell lung cancer, renal cell carcinoma, triple negative breast cancer | Phase I | Unknown | Unknown | NCT03343613 | Terminated |