Table 1.
Clinical trials on MSI CRCs
| Identifier | Phase | Setting | Treatment | Participants | Outcome measures | Estimated Completion date |
|---|---|---|---|---|---|---|
| NCT04008030 | 3 | Advanced dMMR/MSI-H CRCs | Ipilimumab, nivolumab, oxaliplatin, leucovorin, fluorouracil, irinotecan, bevacizumab, cetuximab. | 494 | PFS | July 2025 |
| NCT04118933 | 2 | MSI-H advanced or recurrent CRCs | JS001 | 40 | RECIST v1.1 | July 2021 |
| NCT04001101 | 2 | dMMR/MSI-H metastatic solid tumors | PD-1 and limited metastatic site radiation therapy | 140 | ORR, PFS, OS | July 2021 |
| NCT03926338 | 1/2 | Resectable non-metastatic CRCs with MSI-H | Toripalimab +/− celecoxib | 20 | DFS, OS | May 2022 |
| NCT04304209 | 2/3 | dMMR/MSI-H locally advanced rectal cancer | Sintilimab ± chemoradiotherapy | 195 | CR, R0 resection rate | Oct 2026 |
| NCT04165772 | 2 | Locally advanced dMMR rectal adenocarcinoma | TSR-042, capecitabine or 5-FU, intensity modulated radiation therapy | 30 | pCR | Nov 2021 |
| NCT02715284 | 1 | Advanced solid tumors | TSR-042 | 740 | Safety, ORR | Nov 2023 |
| NCT03311334 | 1/2 | Advanced solid tumors | DSP-7888 dosing emulsion in combination with nivolumab or pembrolizumab | 84 | DLTs, ORR, PFS, OS, DOR, DCR | May 2022 |
| NCT03186326 | 2 | MSI CRCs | FOLFOX or FOLFIRI +/− avelumab | 132 | PFS | March 2025 |
| NCT03436563 | 1/2 | CMS4 mCRCs with MSI or CRC patients with detectable circulating tumor DNA | PD-L1/TGFbetaRII fusion protein M7824 | 74 | ORR, PFS, OS, DFS | Nov 2020 |
| NCT02997228 | 3 | dMMR mCRCs | mFOLFOX6/bevacizumab combination chemotherapy +/− atezolizumab or atezolizumab monotherapy | 347 | PFS, OS, ORR | April 2022 |
| NCT02983578 | 2 | Advanced pancreatic, NSCLC, and dMMR CRCs | AZD9150 (Antisense STAT3) with MEDI4736 | 75 | Disease control, OS, PFS | March 2021 |
| NCT02912559 | 2 | Stage III colon cancer and dMMR | Standard chemotherapy alone or combined with atezolizumab | 700 | DFS, OS | Dec 2020 |
| NCT03841110 | 1 | Advanced solid tumors | FT500, FT500 + nivolumab, pembrolizumab or atezolizumab | 76 | ORR | June 2022 |
| NCT03228667 | 2 | Disease progression following an initial response to PD-1/PD-L1 | ALT-803 + PD-1/PD-L1 checkpoint inhibitor | 611 | ORR, OS | Aug 2020 |
| NCT03667170 | 2 | Advanced dMMR or MSI- H solid tumors | KN035 | 110 | ORR, PFS, OS, DCR | July 2021 |
| NCT03126110 | 1/2 | Advanced or metastatic malignancies | INCAGN01876 + PD-1 or anti-CTLA4 or both | 285 | ORR, OS, PFS | Oct 2021 |
| NCT03538028 | 1 | Advanced malignancies | Anti-LAG-3 INCAGN02385 | 40 | ORR, DCR, DOR | Sep 2020 |
| NCT03607890 | 2 | Advanced dMMR cancers | Nivolumab + relatlimab | 21 | ORR | Oct 2022 |
| NCT03589339 | 1 | Advanced cancers | NBTXR3 + radiotherapy + PD-1 | 60 | anti-tumor response, safety and feasibility | March 2023 |
| NCT03836352 | 2 | Selected advanced & recurrent solid tumors | DPX-Survivac + cyclophosphamide + pembrolizumab | 184 | ORR, PFS, OS, DCR | Dec 2022 |
| NCT02460198 | 2 | Previously treated locally advanced unresectable or metastatic (stage IV) dMMR colorectal carcinoma | Pembrolizumab | 124 | ORR, PFS, OS, DCR, DOR | Aug 2020 |
| NCT02563002 | 3 | dMMR stage IV colorectal carcinoma | Pembrolizumab vs standard therapy | 308 | ORR, PFS, OS | Dec 2021 |
| NCT04301557 | 2 | dMMR/MSI-H locally advanced CRCs | Toripalimab and chemoradiotherapy | 25 | pCR, DFS | Dec 2024 |
| NCT04258111 | 2 | dMMR/MSI-H locally- advanced or metastatic CRCs | IBI310 + sintilimab | 68 | ORR, PFS, DCR | May 2023 |
| NCT03350126 | 2 | dMMR and/or MSI metastatic CRCs | Nivolumab and ipilimumab | 57 | ORR, PFS, OS, DCR | Dec 2020 |
| NCT01885702 | 1/2 | Lynch Syndrome or colorectal cancer with MSI | DC vaccination | 25 | Safety and feasibility, DFS | June 2020 |
Abbreviations: ORR: objective response rate; DCR: disease control rate; DOR: duration of response; PFS: progression-free survival; CR: complete response; PR: partial response; OS: overall survival; DLTs: dose-limiting toxicities; pCR: pathological complete response.