Table 1 ICIs monotherapy and dual strategies involving clinical trials against GCs
Trial | Patient feature | Agent | Target | Phase | Outcomes | Ref. |
|---|---|---|---|---|---|---|
KEYNOTE-012 (NCT01848834) | Advanced GC | Pembrolizumab | PD-1 | Ib | ORR (22%, 95% CI 10–39) and 13% with IRAEs | Muro et al. (2016) [34] |
ATTRACTION-2 (NCT01928394) | Unresectable advanced or recurrent GCs | Nivolumab | PD-1 | III | Positive for OS with 10% with IRAEs | Kang et al. (2017) [13] |
KEYNOTE-059 | Advanced GC after 2 or more lines therapies | Pembrolizumab | PD-1 | II | Response rate 11.6% and complete response in 2.3%; 17.8% cases with IRAEs | Shitara et al. (2018) [42] |
KEYNOTE-061 (NCT02370498) | Advanced GC; CPS ≥ 1 | Pembrolizumab | PD-1 | III | No significant improvement for OS than paclitaxel | Shitara et al. (2018) [11] |
JAVELIN Gastric 100 (NCT02625610) | Advanced GC with 1st line maintenance | Avelumab | PD-1 | III | No significant improvement for OS than chemotherapy | Moehler et al. (2021) [35] |
NCT01585987 | Untreated, unresectable, EGFR2-negative, locally advanced or metastatic GC | Avelumab | PD-1 | III | No significant improvement for OS than chemotherapy | Moehler et al. (2016) [37] |
POLARIS-02 (NCT02915432) | Advanced GC | Toripalimab | PD-1 | Ib/II | Manageable safety profile and promising antitumor activity in advanced GC patients | Wang et al. (2019) [15] |
CheckMate-577 (NCT02743494) | GC or gastroesophageal junction cancer (GEJC) after chemoradiotherapy | Nivolumab | PD-1 | III | DFS was significantly longer in nivolumab group than placebo group | Kelly et al. (2020) [43] |
CheckMate-032 (NCT01928394) | Unresectable advanced, recurrent, or metastatic GC or GEJC | Nivolumab, ipilimumab | PD-1; CTLA4 | I/II | No significant improvement for OS than nivolumab alone | Janjigian et al. (2016) [44] |
NCT02340975 | Chemotherapy-refractory GC or GEJC | Durvalumab, tremelimumab | PD-1; CTLA4 | Ib/II | Low response rates | Kelly et al. (2020) [38] |