Table 1.
Summary of clinical trials targeting Toll-like receptor (TLRs) in combination with immune checkpoint inhibitors.
| TLR targets | Drug name | Combining targets | Drug name | Indications | Phase | Last report status | NCT number | Myeloid-derived suppressor cell as outcome measure |
|---|---|---|---|---|---|---|---|---|
| TLR 3 | Poly-ICLC (agonist) | Anti-PD1 | Pembrolizumab | Colon cancer | I/II | Recruiting | NCT02834052 | No |
| Poly-ICLC (agonist) | Anti-PD-L1 + anti-CTLA-4 | Durvalumab, tremelimumab | Advanced cancers | I/II | Completed | NCT02643303 | No | |
| Rintatolimod (agonist) | Anti-PD1 + chemotherapy | Pembrolizumab, cisplatin | Ovarian cancer | I/II | Recruiting | NCT03734692 | No | |
| Poly-ICLC (agonist) | Anti-PD1 + ultrasound ablation | Advanced solid tumors | I | Recruiting | NCT04116320 | No | ||
| BO-112 (agonist) | Anti-PD1 | Pembrolizumab | Melanoma | II | Active, not recruiting | NCT04570332 | No | |
| TLR 4 | GSK1795091 (agonist) | Anti-PD1 | Pembrolizumab | Advanced solid tumors | I | Completed | NCT03447314 | No |
| TLR 7 | SHR2150 (agonist) | Anti-PD-1 or anti-CD47 + chemotherapy | Solid tumors | I/II | Unknown | NCT04588324 | No | |
| DSP-0509 (agonist) | Anti-PD1 | Pembrolizumab | Advanced solid tumors | I/II | Recruiting | NCT03416335 | No | |
| BNT411 (agonist) | Anti-PD-L1 + chemotherapy | Atezolizumab, carboplatin, and etoposide | Solid tumors | I/Iia | Recruiting | NCT04101357 | No | |
| TLR 8 | Motolimod (agonist) | Anti-PD1 | Nivolumab | Head and neck cancer | I | Completed | NCT03906526 | No |
| Motolimod (agonist) | Anti-PD-L1 | Durvalumab | Ovarian cancer | I/II | Completed | NCT02431559 | No | |
| SBT6050 (agonist) | Anti-PD1 | Pembrolizumab and cemiplimab | Advanced solid tumors expressing HER2 | I/Ib | Active, not recruiting | NCT04460456 | No | |
| TLR 7/8 | TransCon TLR7/8 (agonist) | Anti-PD1 | Pembrolizumab | Advanced or metastatic solid tumors | I/II | Recruiting | NCT04799054 | No |
| BDB018 (agonist) | Anti-PD1 | Pembrolizumab | Advanced solid tumors | I | Recruiting | NCT04840394 | No | |
| BDC-1001 (agonist) | Anti-PD1 | Nivolumab | HER2 positive solid tumors | I/II | Recruiting | NCT04278144 | No | |
| BDB001 (agonist) | Anti-PD-L1 | Atezolizumab | Advanced solid tumors | I | Active, not recruiting | NCT04196530 | No | |
| BDB001 (agonist) | Anti-PD1 | Pembrolizumab | Advanced solid tumors | I | Active, not recruiting | NCT03486301 | No | |
| TLR 9 | MGN1703 (agonist) | Anti-CTLA-4 | Ipilimumab | Advanced solid malignancies and melanoma | I | Active, not recruiting | NCT02668770 | No |
| Tilsotolimod (agonist) | Anti-PD1 + anti-CTLA-4 | Ipilimumab and nivolumab | Advanced cancers | I | Active, not recruiting | NCT04270864 | No | |
| SD-101 (agonist) | Anti-CTLA-4 + radiation | Ipilimumab | B-cell lymphoma | I/II | Completed | NCT02254772 | No | |
| Vidutolimod (agonist) | Anti-PD1 | Nivolumab | Prostate cancer | II | Not yet recruiting | NCT05445609 | No | |
| Vidutolimod (agonist) | Anti-PD1 | Pembrolizumab | Melanoma | II | Recruiting | NCT04708418 | No | |
| SD-101 (agonist) | Anti-PD1 | Pembrolizumab | Pancreatic cancer | I | Recruiting | NCT05607953 | No | |
| DV281 (agonist) | Anti-PD-1 | Non-small cell lung cancer | I | Completed | NCT03326752 | No | ||
| SD-101 (agonist) | Anti-PD1 + radiation | Pembrolizumab | Prostate cancer | II | Active, not recruiting | NCT03007732 | No | |
| Vidutolimod (agonist) | Anti-PD1 | Nivolumab | Melanoma | II | Recruiting | NCT04401995 | No | |
| Vidutolimod (agonist) | Anti-4-1BB/CD137 + anti-PD-L1 | Utomilumab and avelumab | Advanced cancer | Ib/II | Active, not recruiting | NCT02554812 | No | |
| SD-101 (agonist) | Anti-PD1 + anti-CTLA-4 | Nivolumab and Ipilimumab | Melanoma | I | Recruiting | NCT04935229 | No | |
| Vidutolimod (agonist) | Anti-PD1 + anti-CTLA-4 + radiation | Nivolumab, ipilimumab | Colorectal cancer with liver metastases | I | Active, not recruiting | NCT03507699 | No | |
| Vidutolimod (agonist) | Anti-PD1 | Nivolumab | Melanoma | II | Active, not recruiting | NCT03618641 | Yes | |
| SD-101 (agonist) | Anti-PD1 | Nivolumab and radiation therapy | Pancreatic Cancer | I | Active, not recruiting | NCT04050085 | No | |
| SD-101 (agonist) | Anti-PD1 + anti-CTLA-4 | Pembrolizumab, nivolumab and ipilimumab | Primary liver tumors | I/II | Recruiting | NCT05220722 | No | |
| Vidutolimod (agonist) | Anti-OX40 antibody | INCAGN01949 | Pancreatic cancer | Ib/II | Recruiting | NCT04387071 | No | |
| SD-101 (agonist) | Anti-OX40 antibody | BMS-986178 | Advanced solid tumors | I | Active, not recruiting | NCT03831295 | No | |
| SD-101 (agonist) | Anti-OX40 antibody + radiation | BMS-986178 | B-Cell non-Hodgkin lymphomas | I | Active, not recruiting | NCT03410901 | No |
The bold entries mean that they are the clinical trials taking MDSCs as outcome measure.