Table 2.
Clinical trials and outcomes of combined immune checkpoint blockade in HCC.
| Clinical Trial ID | Trial Name | Agents 1 | Setting 2 | Key Outcome 3 |
|---|---|---|---|---|
| Phase I/II | ||||
| NCT01658878 | CheckMate 040 | Nivolumab + Ipilimumab | n = 50 |
ORR: 32% 4 DCR: 54% OS: 22.8 months (9.4–NE) DOR: 17.5 months (4.6–30.5) |
| NCT02519348 | Durvalumab ± Tremelimumab | n = 40 | ORR: 25% 5 DCR: 57.5% |
|
| NCT03680508 | TSR-002 + TSR-042 (Dostarlimab) | first-line, (n = 42) |
ORR | |
| NCT03250832 | TSR-033 + TSR-042 | dose escalation and dose expansion cohorts (n = 200) |
AEs for dose escalation cohort ORR for dose expansion cohort |
|
| NCT03695250 | BMS986205 + Nivolumab | first- or second-line, (n = 23) |
AEs and ORR | |
| Phase III | ||||
| NCT04039607 | CheckMate9DW | Nivolumab + Ipilimumab versus Sorafenib/Lenvatinib | first-line, randomized, open label, (n = 1084) |
OS |
| NCT03298451 | HIMARAYA | Durvalumab ± Tremelimumab versus Sorafenib | first-line, randomized, open label, (n = 1310) |
OS |
1 Bold denotes immune checkpoint inhibitors. 2 n, number of the patients analyzed in the study. The number in the parenthesis shows the number of the planned enrollment. 3 Bold denotes the primary outcome measures of the study. Duration of responses and survival are shown as median values. The numbers in the parenthesis show 95% confidential interval. 4 Yau et al. J Clin Oncol. 2019; 37 (supplement abstract 4012). 5 Kelley et al. J Clin Oncol 2017; 35 (supplement abstract 4073). DOR, duration of response; AEs, adverse events.