Table 8.
Cabozantinib in Combination with ICI: Ongoing Trials in HCC
| Trial Number | Trial Name | Phase | Combined ICI | Setting | Primary Outcomes | Secondary Outcomes |
|---|---|---|---|---|---|---|
| NCT03755791 | COSMIC-312 | III | Atezolizumab | I line | PFS, OS | PFS |
| NCT03170960 | COSMIC-021 | I/II | Atezolizumab | I line | MTD | ORR |
| NCT04442581 | - | II | Pembrolizumab | I line | ORR | ORR, DCR, PFS, OS, AEs |
| NCT01658878a | CheckMate-040 | I/II | Nivolumab/Nivolumab+Ipilimumab | I/II line | AEs, ORR | CRR, DCR, DOR, TTR, TTP, PFS, OS, OSR |
| NCT03539822 | CAMILLA | Ib | Durvalumab | II line | MTD | AEs, ORR, OBR, PFS, OS |
| NCT04514484 | - | I | Nivolumab | Any line PLHIV | DLTs | Immune status, HIV viral loads, ORR |
| NCT03299946a | CaboNivo | Ib | Nivolumab | Neoadjuvant | AEs, treatment completionb | R0 resection, CRR, MPR, ORR, OS, DFS |
Notes: aActive not recruiting, bnumber of patients who complete preoperative treatment and proceed to surgery.
Abbreviations: ICI, immune checkpoint inhibitor; HCC, hepatocellular carcinoma; PFS, progression-free survival; OS, overall survival; MTD, maximum tolerated dose; ORR, objective response rate; DCR, disease control rate; AEs, adverse events; CRR, complete response rate; DOR, duration of response; TTR, time to response; TTP, time to progression; OSR, overall survival rate; OBR, overall benefit rate; PLHIV, people living with HIV; DLTs, incidence of dose-limiting toxicities; HIV, human immunodeficiency virus; R0 resection, microscopically margin-negative resection; MPR, major pathologic response; DFS, disease-free survival.