Table 1.
Summary of selected clinical trials
Author (year) | Phase; NCT | ICI‐based therapeutic regimen | Number of patients (n) | Sponsor |
---|---|---|---|---|
Sangro et al. (2013) |
Pilot study |
2L tremelimumab 15 mg/kg on day 1 of 90‐day cycle | n = 21 | Universidad de Navarra |
El‐Khoueiry et al. (2017) |
Phase I/II |
Dose‐escalation phase [A] 1L/2L nivolumab 0.1–10 mg/kg Q2W Dose‐expansion phase [B] 1L/2L nivolumab 3 mg/kg Q2W |
[A] n = 48 0.1 mg/kg (n = 6) 0.3 mg/kg (n = 9) 1 mg/kg (n = 10) 3 mg/kg (n = 10) 10 mg/kg (n = 13) [B] n = 214 |
Bristol‐Myers Squibb |
Yen et al. (2017) |
Phase Ia/Ib |
2L BGB‐A317 (tislelizumab) 5 mg/kg Q3W | n = 11 | BeiGene |
Wainberg et al. (2017) |
Phase I/II NCT01693562 |
2L durvalumab 10 mg/kg Q2W | n = 40 | MedImmune LLC |
Kelley et al. (2017) |
Phase I/II |
2L durvalumab 20 mg/kg + tremelimumab 1 mg/kg Q4W (four doses) Followed by durvalumab 20 mg/kg Q4W |
n = 40 | MedImmune LLC |
Pishvaian et al. (2018) |
Phase Ib |
1L atezolizumab 1,200 mg + bevacizumab 15 mg/kg Q3W | n = 68 | Hoffmann‐La Roche |
Zhu et al. (2018) |
Phase II |
2L pembrolizumab 200 mg Q3W | n = 104 | MSD |
Finn et al. (2019) |
Phase III |
2L pembrolizumab 200 mg Q3W + BSC | n = 278 | MSD |
Floudas et al. (2019) |
Pilot study; NCT02821754 |
2L tremelimumab 75 mg + durvalumab 1,500 mg (four doses) Followed by durvalumab 1,500 mg |
n = 10 | National Cancer Institute |
Kudo et al. (2019a) |
Phase I/II |
1L/2L nivolumab 240 mg Q2W | n = 49 | Bristol‐Myers Squibb |
Kudo et al. (2019b) |
Phase Ib |
1L avelumab 10 mg/kg Q2W + axitinib 5 mg BID | n = 22 | Pfizer |
Yau et al. (2019a) |
Phase I/II |
Arm [A]: 2L nivolumab 1 mg/kg + ipilimumab 3 mg/kg Q3W (four doses) Arm [B]: 2L nivolumab 3 mg/kg + ipilimumab 1 mg/kg Q3W (four doses) Arm [C]: 2L nivolumab 3 mg/kg Q2W + ipilimumab 1 mg/kg Q6W |
[A] n = 50 [B] n = 49 [C] n = 49 |
Bristol‐Myers Squibb |
Yau et al. (2019b) |
Phase III |
1L nivolumab 240 mg Q2W | n = 371 | Bristol‐Myers Squibb |
Finn et al. (2020) |
Phase III |
1L atezolizumab 1,200 mg + bevacizumab 15 mg/kg Q3W | n = 336 | Hoffmann‐La Roche |
Yau et al. (2020) |
Phase I/II |
Arm [A]: 1L/2L nivolumab 240 mg Q2W + cabozantinib 40 mg daily Arm [B]: 1L/2L nivolumab 3 mg/kg Q2W + cabozantinib 40 mg daily + ipilimumab 1 mg/kg Q6W |
[A] n = 36 [B] n = 35 |
Bristol‐Myers Squibb |
Finn et al. (2020) |
Phase Ib NCT03006926 | 1L lenvatinib daily + pembrolizumab 200 mg Q3W | n = 100 | Eisai Co. Ltd. |
Qin et al. (2020) |
Phase II |
[A] 2L camrelizumab 3 mg/kg Q2W [B] 2L camrelizumab 3 mg/kg Q3W |
[A] n = 109 [B] n = 108 |
Jiangsu Hengrui |
Abbreviations: 1L, first‐line treatment (sorafenib‐naïve); 2L, second‐line treatment (sorafenib‐experienced); BID, twice a day; BSC, best supportive care; ICI, immune‐checkpoint inhibitor; MSD, Merck Sharp & Dohme; Q2W, every 2 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks; Q6W, every 6 weeks.