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. 2022 Jan 27;14(1):140–157. doi: 10.4254/wjh.v14.i1.140

Table 2.

Ongoing clinical trials for immune checkpoint inhibitor therapy

Identifier
Type of study
Study design
Status/outcome
NCT02576509 (CheckMate-459) Global phase III randomized control trial Comparing nivolumab with sorafenib as first treatment in advanced HCC Recruitment closed; Results awaited
NCT01658878 Phase I/II dose-escalation, open-label, non-comparative study Phase 1 to establish the safety of nivolumab at different dose; Phase 2 to compare the efficacy of nivolumab and sorafenib; To study the safety and efficacy of the combination of nivolumab plus ipilimumab and nivolumab plus cabozantinib Active, not recruiting
NCT03298451 Randomized phase III HIMALAYA trial To compare the combination of tremelimumab (CTLA-4 inhibitor) and durvalumab (PD-L1 inhibitor) vs sorafenib Recruiting patients
NCT03680508 Phase II trial To test efficacy of TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) on advanced HCC Recruiting patients
NCT02947165 Phase I/Ib study Anti-TGF-β monoclonal antibody NIS793 and PD-1 inhibitor spartalizumab in breast, lung, colorectal, pancreatic, renal, and HCC Active, not recruiting
NCT03412773 Phase III randomized, open-label, multicenter, global study To compare the efficacy and safety of tislelizumab vs sorafenib in unresectable HCC Active, not recruiting
NCT03434379 (IMbrave150)[51] Phase III study To evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in locally advanced or metastatic HCC; To determine overall survival Atezo + Bevac showed improved survival at 18 mo (52%) with clinically meaningful treatment benefit and safety. The trial confirmed atezo + bevac as a standard of care for previously untreated, unresectable HCC
NCT02702401 (MK-3475-240/KEYNOTE-240) Phase III study Pembrolizumab (MK-3475) in advanced HCC treated systemically as a second line therapy; To determine overall survival and progression free survival Active, not recruiting
NCT03062358 (MK-3475-394/KEYNOTE-394) Phase III study To determine the efficacy and safety of pembrolizumab or placebo with best supportive care previously systemically treated HCC Active, not recruiting
NCT03383458 (CheckMate 9DX) Phase III study To investigate if nivolumab will improve recurrence-free survival compared to placebo in HCC undergone complete resection Active, not recruiting

CTLA-4: Cytotoxic T lymphocyte protein 4; PD-1: Programmed cell death protein 1; HCC: Hepatocellular carcinoma; TGF: Transforming growth factor; TIM3: T cell immunoglobulin and mucin domain-containing protein 3.