Clinical trials of ICIs in early-stage MSI colon and rectal cancer

StudiesNCTDrug (NA/A)NC/RpCR (%)Duration (w)WW (%)DFR (%)
3-year
Ref.
Chalabi, 2020NCT03026140Nivolumab/ipilimumab (NA)20C606--[17]
Chalabi, 2024NCT03026140Nivolumab/ipilimumab (NA)119C676-100[16]
de Gooyer, 2024NCT03026140Nivolumab/relatlimab (NA)59C676--[23]
Hu, 2022NCT03926338Toripalimab +/– celecoxib (NA)34C88 vs 6512--[25]
Xu, 2024NCT05890742IBI301 + sintilimab
vs sintilimab (NA)
101C80 vs 476--[22]
Shiu, 2024NCT05197322Pembrolizumab (NA)32C596--[27]
Ludford, 2023NCT04082572Pembrolizumab (NA)27C6624--[28]
AZUR2, 2024NCT05855200Dostarlimab vs SOC (NA/A)711C-12--
Yu, 2024NCT04715633Camrelizumab + afatinib (NA)52C/R6112–2454-[24]
de la Fouchardiere, 2024NCT04795661Pembrolizumab (NA/A)87C/R47 vs 683–6--[26]
Cercek, 2022NCT04165772Dostarlimab (NA)41*R-24100-[29]
Chen, 2023NCT04304209Sintilimab +/– CHT (NA/A)17R-1253-[31]
AZUR1, 2024NCT05723562Dostarlimab (NA)100R-24--

ICIs: immune checkpoint inhibitors; MSI: microsatellite unstable; nivolumab: anti-PD-1; ipilimumab: anti-CTLA4; relatlimab: anti-LAG3; toripalimab: anti-PD-1; celecoxib: COX2 inhibitor; pembrolizumab: anti-PD-1; camrelizumab: anti-PD-1; afatinib: VEGF inhibitor; IBI301: anti-CTLA4; sintilimab: anti-PD-1; dostarlimab: anti-PD-1. NCT: National Clinical Trial; NA: neoadjuvant; A: adjuvant; CHT: chemotherapy; pCR: pathological complete response; WW: watch and wait; DFS: disease-free survival; C/R: colon/rectum; SOC: standard of care; Ref.: reference. * Updated information