Table 2.
List of major ongoing phase I-III trials with immune checkpoint inhibitors in gastric cancer.
| Study Name (NCT Number) |
Country | Phase | Line | N | Drugs (Target) | Selected Population | Study Intervention I Experimental Arm/Control Arm or II Experimental Arm |
Primary Endpoint |
|---|---|---|---|---|---|---|---|---|
| Non-metastatic gastric cancer | ||||||||
| Keynote-585 (NCT03221426) |
Global | III | Perioperative | NA | Pembrolizumab (PD-1) | All comers | fluorouracil/capecitabine plus cisplatin or FLOT +/- pembrolizumab | OS EFS pCR |
| IMAGINE (NCT04062656) |
Western | rII | Perioperative | NA | Nivolumab (PD-1) Ipilimumab (CTLA-4) Relatlimab (LAG-3) |
All comers | FLOT Nivolumab Nivolumab + ipilimumab Nivolumab + relatlimab |
pCR |
| NCT04354662 | Asian | II | Perioperative | NA | Toripalimab (PD-1) | All comers | FLOT + toripalimab | DFS |
| ICONIC (NCT03399071) |
Western | II | Perioperative | NA | Avelumab (PD-L1) | All comers | FLOT + avelumab | pCR |
| NCT03878472 | Asian | II | Neoadjuvant | NA | SHR1210 (PD-1) | All comers | SHR1210 SHR1210 + Apatinib SHR1210 + Apatinib + S-1 SHR1210 + Apatinib+ S-1 + oxaliplatin |
pRR |
| Checkmate-577 (NCT02743494) |
Global | III | Adjuvant | 794 | Nivolumab (PD-1) | All comers | Nivolumab versus placebo after neoadjuvant chemoradiotherapy and surgery | DFS |
| EORTC VESTIGE (NCT03443856) |
Western | rII | Adjuvant | NA | Nivolumab (PD-1) Ipilimumab (CTLA-4) |
All comers | Nivolumab + ipilimumab versus FLOT after neoadjuvant FLOT and surgery | DFS |
| Metastatic gastric cancer | ||||||||
| Keynote-859 (NCT03675737) |
Global | III | 1° | NA | Pembrolizumab (PD-1) | HER-2 negative | cisplatin plus 5-fluorouracil/Xelox +/- pembrolizumab | OS PFS |
| Keynote-811 (NCT03615326) |
Global | III | 1° | NA | Pembrolizumab (PD-1) | HER-2 positive | cisplatin plus 5-fluorouracil/Xelox/Folfox/S-1 oxaliplatin + trastuzumab +/- pembrolizumab | PFS OS |
| APICAL-GE (NCT04278222) |
Asian | II | 1° | NA | Toripalimab (PD-1) | MSS | Anlotinib Plus Toripalimab | ORR |
| NCT04202484 | Asian | II | 1° | NA | Toripalimab (PD-1) | HER-2 negative | Toripalimab combined with oxaliplatin and Tegafur, Gimeracil and Oteracil Porassium Capsules | ORR |
| SHR-1210-III-316 (NCT04342910) |
China | III | 2° | 550 | Camrelizumab (PD-1) Apatinib (VEGFR2) |
All comers | Camrelizumab + apatinib paclitaxel or irinotecan |
OS |
| NCT04435652 | Asia | II-III | 2° | 492 | QL1604 (PD-1) | HER-2 negative | QL1604 + nab-paclitaxel followed by QL1604 maintenance paclitaxel alone |
ORR, safety, OS |
| SEQUEL (NCT04069273) |
USA | rII | ≥2° | 58 | Pembrolizumab (PD-1) Ramucirumab (VEGFR2) |
All comers | Paclitaxel + ramucirumab + pembrolizumab (patient-tailored algorithm) Paclitaxel + ramucirumab + pembrolizumab |
ORR |
| DURIGAST (PRODIGE59-FFCD1707) (NCT03959293) |
France | rII | 2° | 105 | Durvalumab (PD-L1) Tremelimumab (CTLA-4) |
All comers | FOLFIRI + durvalumab + tremelimumab FOLFIRI + durvalumab |
PFS |
| ESR-15-11655 (NCT03579784) | Korea | II | 2° | 40 | Durvalumab (PD-1) Olaparib (PARP) |
All comers | Paclitaxel + olaparib + durvalumab | DCR |
| NCC2070 (NCT04140318) |
China | II | 2° | 60 | Sintilimab (PD-1) | All comers | Nab-paclitaxel + sintilimab | ORR |
| ASGARD (NCT04089657) |
China | II | ≥3° | 40 | Sintilimab (PD-1) Apatinib (VEGFR2) |
All comers | Apatinib + sintilimab | DCR |
| RiME (NCT03995017) |
USA | II | 2°–3° | 61 | Nivolumab (PD-1) Rucaparib (PARP) Ramucirumab (VEGFR2) |
All comers | Rucaparib + ramucirumab + nivolumab Rucaparib + ramucirumab |
ORR |
| RAP (AIO-STO-0218) (NCT03966118) |
Germany | II | 2° | 59 | Avelumab (PD-1) Ramucirumab (VEGFR2) |
All comers | Paclitaxel + ramucirumab + avelumab | OS |
| WaKING (NCT04166721) |
UK | II | ≥2° | 52 | Atezolizumab (PD-L1) DKN-01 (DKK1) |
MSS/pMMR | Atezolizumab + DKN-01 | Safety, ORR |
| NCT03694977 | Korea | II | >2° | 30 | Lacnotuzumab (CSF-1) Spartalizumab (PD-1) |
All comers | Lacnotuzumab + Spartalizumab | Biomarker analysis |
| NCT04592211 | Korea | I-II | 2° | 71 | Pembrolizumab (PD-1) Olaparib (PARP) |
HRR/MSS | Pembrolizumab + olaparib + paclitaxel | PFS DLT |
| NCT04209686 | Australia, USA | II | 2° | 36 | Pembrolizumab (PD-1) Olaparib (PARP) |
All comers | Pembrolizumab + olaparib + paclitaxel | OS |
| da VINci (NCT03784040) |
Asia | Ib | >2° | 40 | OTSGC-A24 (cancer vaccine) Nivolumab (PD-1) Ipilimumab (CTLA-4) |
All comers | OTSGC-A24 + nivolumab OTSGC-A24 + nivolumab + ipilimumab |
Safety, ORR |
Legend: N: patient number; r: randomized; CPS: combined positive score for PD-L1 status; MSS/pMMR: microsatellite stable/mismatch repair proficient; DLT: dose-limiting toxicity; DCR: disease control rate; DOR: duration of response; ORR: objective response rate; OS: overall survival; EFS: event free survival; pCR: pathological complete response; PFS: progression-free survival; NA: not applicable; pRR: pathological remission rate.