Table 2.
Major trials in HCC involving anti-PD-1/PD-L1 agents-based immunotherapies.
| Name | Phase | Line of Treatment | Strategy | Primary Endpoint |
|---|---|---|---|---|
| NCT03841201 | 2 | I | Nivolumab (anti-PD-1/PD-L1) + Lenvatinib (VEGFRs inhibitor) | ORR (Objective response rate) Safety and tolerability |
| NCT03630640 | 2 | neo + adj | Nivolumab | RFS (Recurrence Free Survival) |
| NCT02576509 | 3 | I | Nivolumab vs. Sorafenib (Raf inhibotor) | OS (Overall Survival) |
| NCT03203304 | 1 | II | Nivolumab Ipilimumab (anti CTLA-4) | AEs (Adverse Events) |
| NCT01658878 | 1/2 | I | Nivolumab Sorafenib Nivolumab + Ipilimumab Nivolumab + Cabozantinib (RTK inhibitor) Nivolumab + Ipilimumab + Cabozantinib |
AEsORR |
| NCT03510871 | 2 | neo | Nivolumab + Ipilimumab | Tumor shrinkage |
| NCT03841110 | 1 | II | FT500 (NK cell product) +/− Nivolumab, Pembrolizumab (anti-PD-1/PD-L1), Atezolizumab (anti PD-L1), Cyclophosphamide, Fludarabine | DLT (Dose Limiting Toxicities) |
| NCT03682276 | 1/2 | I | Ipilimumab + Nivolumab | Delay to surgery AEs |
| NCT03228667 | 2 | II | ALT-803 (IL-15 superagonist) + Pembrolizumab ALT-803 + Nivolumab ALT-803 + Atezolizumab ALT-803 + Avelumab (anti PD-L1) |
ORR |
| NCT04134559 | 2 | II | Pembrolizumab | irBOR (immune-related Best Overall Response) |
| NCT02595866 | 1 | II | Pembrolizumab | AEs ECIs (Events of Clinical Interest) |
| NCT03337841 | 2 | neo + adj | Pembrolizumab | One-year RFS |
| NCT04099277 | 1 | II |
LY343515 1+/− Pembrolizumab |
DLT |
| NCT03222076 | 2 | neo | Nivolumab +/− Ipilimumab |
AEs |
| NCT03383458 | 3 | adj | Nivolumab | RFS |
| NCT03655002 | 1 | II | Nivolumab, Cyclophosphamide, IRX-2 (cytokine-based biologic agent) | Safety |
| NCT03812562 | 1 | I | Yttrium Y 90 glass microspheres, Nivolumab | RR (Recurrence Rate) |
| NCT03867084 | 3 | adj | Pembrolizumab | RFS OS |
| NCT03755739 | 2/3 | I | Pembrolizumab | OS |
| NCT02702401 | 3 | II | Pembrolizumab | PFS OS |
| NCT03062358 | 3 | II | Pembrolizumab | OS |
| NCT02702414 | 2 | II | Pembrolizumab | ORR |
| NCT03006926 | 1 | II | Pembrolizumab + Levantinib | AEs DLT |
| NCT03713593 | 3 | I | Levantinib +/− Pembrolizumab | OS |
| NCT02940496 | 1/2 | II | Pembrolizumab Pembrolizumab + elbasvir/grazoprevir + ribavirin (antiviral drugs) |
DLT |
| NCT03511222 | 2 | I | Vorolanib (antiangiogenic agent) + Pembrolizumab | RP2D (Recommended phase II dose) |
| NCT03299946 | 1 | neo | Cabozantinib + Nivolumab | AEs proceed to surgery |
| NCT03412773 | 3 | I | Tislelizumab (anti PD-1/PD-L1) | OS ORR |