Table 1.
Current clinical trials of immune checkpoint inhibitors for HCC.
| Drug | ClinicalTrials.gov identifier | Phase | n | Line of therapy | Endpoint | Status |
|---|---|---|---|---|---|---|
| Nivolumab | ||||||
| Nivolumab | NCT01658878 | I/II | 42 | 1L/2L | DLT/MTD | Completed |
| Nivolumab | NCT01658878 | I/II | 214 | 1L/2L | ORR | Completed |
| Nivolumab | NCT01658878 | I/II | 200 | 1L | ORR | Completed |
| Nivolumab | NCT01658878 | I/II | 262 | 1L/2L | AEs | Completed |
| Nivolumab | NCT02576509 | III | 726 | 1L | TTP/OS | Recruiting |
| Nivolumab | NCT03383458 | III | 520 | Adjuvant | ||
| Pembrolizumab | ||||||
| Pembrolizumab | NCT02702414 | II | 100 | 2L | ORR | Completed |
| Pembrolizumab | NCT02702401 | III | 408 | 2L | PFS/OS | Recruiting |
| Pembrolizumab | NCT03062358 | III | 330 | 2L | OS | Recruiting |
| Pembrolizumab | NCT03211416 | I-II | 27 | 1L | ORR | Recruiting |
| Relatlimab | NCT01968109 | I-II | 168 | 2L | AEs/ORR | Recruiting |
| LY3321367/ LY3300054 |
NCT03099109 | I | 196 | 2L | DLT | Recruiting |
| BGB-A317 | NCT03412773 | III | 660 | 1L | OS | Recruiting |
| SHR-1210 | NCT02989922 | II | 220 | 2L | ORR | Completed |
| REGN3767 | NCT03005782 | I | 546 | 2L | ORR | Recruiting |
| Combinations with other immunotherapies | ||||||
| Nivolumab/ Ipilimumab | NCT01658878 | II | 620 | 2L | AEs | Completed |
| Nivolumab/ ipilimumab | NCT03222076 | II | 45 | Neoadjuvant | AEs | Recruiting |
| Nivolumab/ Ipilimumab | NCT03510871 | II | 40 | Neoadjuvant | ORR | Recruiting |
| Nivolumab/ Pexavec |
NCT03071094 | II | 30 | 2L | DLT/ORR | Recruiting |
| Durvalumab/ Tremelimumab |
NCT02519348 | II | 545 | 1L/2L | AEs | Recruiting |
| Durvalumab/ Tremelimumab | NCT03298451 | III | 1200 | 1L | OS | Recruiting |
| Relatlimab/ Nivolumab | NCT01968109 | I-II | 168 | 2L | AEs/ORR | Recruiting |
| REGN3767/ REGN2810 | NCT03005782 | I | 546 | 2L | ORR | Recruiting |
| LY3321367/ LY3300054 |
NCT03099109 | I | 196 | 2L | DLT | Recruiting |
| Atezolizumab/ bevacizumab |
NCT03434379 | III | 480 | 1L | OS/ PFS | Recruiting |
| Combinations with targeted agents | ||||||
| PDR001/ FGF401 |
NCT02325739 | II | 238 | 2L | DLT/TTP/ORR | Recruiting |
| PDR001/ INC280 |
NCT02795429 | II | 108 | 2L | DLT/ORR | Recruiting |
| Nivolumab/ Galunisertib | NCT02423343 | II | 75 | 2L | MTD | Completed |
| Regorafenib/ pembrolizumab | NCT03347292 | I | 40 | 1L | AEs/ DLT | Recruiting |
| Cabozantinib/ nivolumab | NCT03299946 | I | 15 | Neoadjuvant | AEs | Recruiting |
| Nivolumab/ CC-122 | NCT02859324 | I-II | 50 | 2L | AEs/ DLT/ ORR | Recruiting |
| PDR001/ Sorafenib |
NCT02988440 | II | 50 | 2L | AEs | Recruiting |
| Pembrolizumab/ Lenvatinib | NCT03006926 | I | 104 | 2L | AEs/ DLT | Recruiting |
| Combinations with locoregional therapies | ||||||
| Nivolumab/ TACE |
NCT03143270 | I | 14 | 2L | AEs | Recruiting |
| Nivolumab/ Y90 |
NCT03033446 | II | 40 | 2L | ORR | Recruiting |
| Nivolumab/ Y90 |
NCT02837029 | I | 35 | 2L | MTD | Recruiting |
| Pembrolizumab/ Y90 |
NCT03099564 | II | 30 | 2L | PFS | Recruiting |
AE, Adverse Event; DLT, dose-limiting toxicity; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TTP, time to progression.