Table 1.
Characteristics of included studies
|
Ref.
|
Trial
|
Clinical trials. gov, No.
|
Study design
|
Phase
|
Case, experimental vs control, (n)
|
Intervention methods
|
ORR (%)
|
DCR (%)
|
12-mo OS (%)
|
12-mo PFS (%)
|
| Bang et al[28] 2018 | JAVELIN Gastric 300 | NCT02625623 | RCT | III | 371, 185 vs 186 | Avelumab 10 mg/kg Q2 W vs paclitaxel 80 mg/m2 or irinotecan 150 mg/m2 1, 8, 15 d of 4-wk cycles. | 2.2 | 22.2 | NA | NA |
| Bang et al[29] 2019 | KEYNOTE-059 (cohorts 2 and 3) | NCT02335411 | Single-arm | II | 31 | Pembrolizumab 200 mg on day 1 of 21-d cycles. | 25.8 | 35.5 | 63.0 | NA |
| Boku et al[30] 2019 | ATTRACTION-4 | NCT02746796 | RCT | II | 40, 21 vs 19 | Nivolumab 360 mg Q3 W + SOX or Cape OX. | 65.8 | 84.2 | NA | NA |
| Chen et al[31] 2020 | ATTRACTION-2 | NCT02267343 | RCT | III | 493, 330 vs 163 | Nivolumab 3 mg/kg Q2 W vs placebo 3 mg/kg Q2 W. | 11.9 | 40.3 | 87.1 | 9.3 |
| Chung et al[32] 2019 | JAVELIN Solid Tumor | NCT01772004 | Dose-escalation | I | 150 | Avelumab 10 mg/kg Q2 W. | 6.7 | 45.3 | 38.0 | 12.6 |
| Doi T et al[33] 2019 | JAVELIN Solid Tumor JPN trial | NCT01943461 | Single-arm | I | 40 | Avelumab 10 mg/kg Q2 W | 10.0 | 52.5 | 31.0 | NA |
| Fuchs et al[34] 2018 | KEYNOTE-059 (cohorts 1) | NCT02335411 | Single-arm | II | 259 | Pembrolizumab 200 mg Q3 W. | 11.6 | 27.0 | 23.4 | NA |
| Herbst et al[35] 2019 | JVDF | NCT02443324 | Single-arm | Ia/b | 41 | Pembrolizumab 200 mg on day 1 + ramucirumab 10 mg/kg days 1-8. | 7.3 | 51.2 | 30.8 | 12.3 |
| Janjigian et al[36] 2018 | CheckMate-032 | NCT01928394 | Dose-escalation | I/II | 59 | Nivolumab 3 mg/kg Q2 W. | 12.0 | 32.0 | 39.0 | 8.0 |
| Kelly et al[37] 2020 | NA | NCT02340975 | RCT | Ib/II | 27 | Durvalumab 20 mg/kg + tremelimumab 1 mg/kg Q4W. | 7.4 | NA | 37.0 | NA |
| Muro et al[38] 2016 | KEYNOTE-012 | NCT01848834 | Single-arm | Ib | 39 | Pembrolizumab 10 mg/ kg Q2 W. | 22.0 | 33.0 | 42.0 | NA |
| Shah et al[39] 2019 | KEYNOTE-180 | NCT02559687 | Single-arm | II | 121 | Pembrolizumab 200 mg Q3 W. | 9.9 | 30.6 | 28.0 | NA |
| Shitara et al[40] 2018 | KEYNOTE-061 | NCT02370498 | RCT | III | 592, 296 vs 296 | Pembrolizumab 200 mg Q3 W vs paclitaxel 80 mg/m2 1, 8, 15 d of 4-wk cycles | 11.1 | 20.7 | 40.0 | NA |
ORR: Objective response rate; DCR: Disease control rate; OS: Overall survival; PFS: Progression-free survival; RCT: Randomized controlled trial; NA: Not available.