Table 2.
Ongoing clinical trials of immune checkpoint therapy combined with targeted therapy in hepatocellular carcinoma
| Conditions | Strategies | Phases | Enrollment | Study Designs | NCT Number | Status |
|---|---|---|---|---|---|---|
| HCC | Nivolumab + ipilimumab + cabozantinib | Phase 1/2 | 620 | Non-Randomized | NCT01658878 | Active, not recruiting |
| HCC | Durvalumab + tremelimumab, durvalumab + bevacizumab | Phase 2 | 545 | Randomized | NCT02519348 | Recruiting |
| Solid tumors (including HCC) | Mogamulizumab (CCR4 antagonist) + nivolumab | Phase 1/2 | 114 | Single Group Assignment | NCT02705105 | Completed |
| Gastrointestinal or thoracic malignancies (including HCC) | Ramucirumab + MEDI4736 (PD-L1 inhibitor) | Phase 1 | 114 | Non-Randomized | NCT02572687 | Active, not recruiting |
| HCC | Pembrolizumab + lenvatinib | Phase 1 | 97 | Single Group Assignment | NCT03006926 | Active, not recruiting |
| Solid tumors (including HCC) | Atezolizumab + cabozantinib | Phase 1/2 | 1732 | Non-Randomized | NCT03170960 | Recruiting |
| HCC | Avelumab + axitinib | Phase 1 | 22 | Non-Randomized | NCT03289533 | Active, not recruiting |
| HCC | Pembrolizumab + sorafenib tosylate | Phase 1/2 | 27 | Single Group Assignment | NCT03211416 | Recruiting |
| HCC | Nivolumab + cabozantinib | Phase 1 | 15 | Single Group Assignment | NCT03299946 | Recruiting |
| HCC | Nivolumab + lenvatinib | Phase 1 | 30 | Non-Randomized | NCT03418922 | Active, not recruiting |
| HCC | Nivolumab + sorafenib | Phase 2 | 40 | Non-Randomized | NCT03439891 | Recruiting |
| HCC | Atezolizumab + bevacizumab | Phase 3 | 480 | Randomized | NCT03434379 | Recruiting |
| HCC | Nivolumab + bevacizumab | Phase 1 | 12 | Single Group Assignment | NCT03382886 | Active, not recruiting |
| HCC | Pembrolizumab + bavituximab | Phase 2 | 34 | Single Group Assignment | NCT03519997 | Recruiting |
| Solid tumors (including HCC) | Avelumab + regorafenib | Phase 1/2 | 362 | Non-Randomized | NCT03475953 | Recruiting |
| HCC | Pembrolizumab + regorafenib | Phase 1 | 40 | Non-Randomized | NCT03347292 | Recruiting |
| HCC | APL-501 (PD-1 inhibitor) + APL-101 (c-MET inhibitor) | Phase 1/2 | 119 | Non-Randomized | NCT03655613 | Recruiting |
| Solid tumors (including HCC) | Nivolumab + vorolanib, pembrolizumab + vorolanib | Phase 1 | 56 | Non-Randomized | NCT03511222 | Recruiting |
| Gastrointestinal malignancies (including HCC) | Durvalumab + cabozantinib | Phase 1 | 30 | Single Group Assignment | NCT03539822 | Recruiting |
| HCC | Atezolizumab + cabozantinib | Phase 3 | 740 | Randomized | NCT03755791 | Recruiting |
| HCC | Pembrolizumab + lenvatinib | Phase 3 | 750 | Randomized | NCT03713593 | Recruiting |
| HCC | Durvalumab + bevacizumab | Phase 3 | 888 | Randomized | NCT03847428 | Recruiting |
| HCC | Nivolumab + lenvatinib | Phase 2 | 50 | Single Group Assignment | NCT03841201 | Recruiting |
| HCC | Nivolumab + GT90001 (angiogenesis inhibitor) | Phase 1/2 | 20 | Single Group Assignment | NCT03893695 | Recruiting |
| HCC | Durvalumab + tivozanib | Phase 1/2 | 42 | Sequential Assignment | NCT03970616 | Not yet recruiting |
| HCC | Nivolumab + lenvatinib | Phase 2/3 | 216 | Randomized | NCT04044651 | Not yet recruiting |
| HCC | Atezolizumab + bevacizumab | Phase 3 | 662 | Randomized | NCT04102098 | Not yet recruiting |
| Selected cancers (including HCC) | MK-3475 (PD-1 inhibitor) + INCB024360 (IDO inhibitor) | Phase 1/2 | 444 | Non-Randomized | NCT02178722 | Active, not recruiting |
| Solid tumors (including HCC) | Nivolumab + galunisertib (TGF-β inhibitor) | Phase 1/2 | 75 | Non-Randomized | NCT02423343 | Active, not recruiting |
| HCC | Nivolumab + CC-122 (CRBN protein modulator) | Phase 1/2 | 21 | Single Group Assignment | NCT02859324 | Active, not recruiting |
| HCC | Nivolumab + SF1126 (PI3K inhibitor) | Phase 1 | 14 | Single Group Assignment | NCT03059147 | Active, not recruiting |
| Selected cancers (including HCC) | Pembrolizumab + INCAGN01876 (GITR stimulant) + Epacadostat(IDO inhibitor) + pembrolizumab | Phase 1/2 | 10 | Single Group Assignment | NCT03277352 | Active, not recruiting |
| HCC | Nivolumab + BMS-986205 (IDO1 inhibitor) | Phase 1/2 | 23 | Single Group Assignment | NCT03695250 | Recruiting |
| Solid tumors (including HCC) | Nivolumab + copanlisib (PI3K inhibitor) | Phase 1/2 | 160 | Non-Randomized | NCT03735628 | Recruiting |
| Selected cancers (including HCC) | Atezolizumab + KY1044 (ICOS agonist) | Phase 1/2 | 412 | Non-Randomized | NCT03829501 | Recruiting |
| HCC | Nivolumab + abemaciclib (CDK4 inhibitor) | Phase 2 | 27 | Single Group Assignment | NCT03781960 | Not yet recruiting |
| HCC | Nivolumab + cabiralizumab (CSF1R antagonist), nivolumab + BMS-986253 (IL-8 inhibitor) | Phase 2 | 74 | Randomized | NCT04050462 | Not yet recruiting |
| Advanced cancer (including HCC) | Pembrolizumab/nivolumab/atezolizumab/avelumab + ALT-803 (IL-15R agonist) | Phase 2 | 611 | Non-Randomized | NCT03228667 | Recruiting |
| Liver cancer | TSR-022 (HAVCR2 protein inhibitor) + TSR-042 (PD-1 inhibitor) | Phase 2 | 42 | Single Group Assignment | NCT03680508 | Not yet recruiting |
| HCC or NSCLC | Nivolumab + BMS-813160 (CCR2 antagonist), nivolumab + BMS-986253 (IL-8 inhibitor) | Phase 2 | 50 | Randomized | NCT04123379 | Not yet recruiting |
BTC: Bile tract carcinoma; CCR: C-C motif chemokine receptor; CDK4: Cyclin dependent kinase 4; CRBN: Cereblon; CSF1R: Colony stimulating factor 1 receptor; CTLA-4: Cytotoxic T lymphocyte-associated antigen 4; GITR: Glucocorticoid-induced TNF receptor; HAVCR2: Hepatitis A virus cellular receptor 2; HCC: Hepatocellular carcinoma; ICOS: Inducible T cell co-stimulator; IDO: Indoleamine 2,3-dioxygenase; IL: Interleukin; LAG-3: Lymphocyte activation gene-3; NSCLC: Non-small-cell lung cancer; PD-1: Programmed cell death protein-1; PD-L1: programmed cell death protein ligand-1; PI3K: Phosphatidylinositol 3-kinase; TGF-β: Transforming growth factor-β.