Table 2.
Clinical trials of neoantigens in colorectal cancer.
| Type of therapy | Study phase | Tumor | Status of CRC | Strategy | Combination therapy | Number of patients | Status | Trail number |
|---|---|---|---|---|---|---|---|---|
| Vaccine | Phase I | Pancreatic cancer metastatic Colorectal cancer metastatic |
MMR-p | Neoantigen vaccine with poly-ICLC adjuvant | Retifanlimab | 12 | Not yet recruiting | NCT04799431 |
| Vaccine | Phase I/II | Colorectal cancer | Germline MMR-d, MSI-positive | Vaccination with frameshift-derived neoantigen-loaded DC | — | 25 | Active, not recruiting | NCT01885702 |
| Vaccine | Phase I | Gastric cancer Hepatocellular carcinoma Non-small-cell lung cancer Colorectal cancer |
— | Neoantigen-primed DC cell vaccine | — | 80 | Recruiting | NCT04147078 |
| Vaccine | Phase I/II | Non-small-cell lung cancer Colorectal cancer Gastroesophageal adenocarcinoma Urothelial carcinoma |
MSS | GRT-C901/GRT-R902, a neoantigen cancer vaccine | Nivolumab and ipilimumab | 214 | Recruiting | NCT03639714 |
| Vaccine | Phase I/II | Non-small-cell lung cancer Colorectal cancer Pancreatic cancer Solid tumor Shared neoantigen-positive solid tumors |
MSS | GRT-C903 and GRT-R904, a shared neoantigen-based therapeutic cancer vaccine | Nivolumab and ipilimumab | 144 | Recruiting | NCT03953235 |
| Vaccine | Phase I | Colorectal cancer Pancreatic cancer |
MMR-p | Pooled mutant-KRAS peptide vaccine with poly-ICLC | Nivolumab and ipilimumab | 30 | Recruiting | NCT04117087 |
| Vaccine | Not applicable | Advanced esophageal squamous carcinoma Gastric adenocarcinoma Pancreatic adenocarcinoma Colorectal adenocarcinoma |
— | Personalized mRNA tumor vaccine encoding neoantigen | — | 24 | Recruiting | NCT03468244 |
| Vaccine | Phase I | Colorectal adenocarcinoma Pancreatic ductal adenocarcinoma |
— | Personalized synthetic tumor-associated peptide vaccine | Imiquimod, pembrolizumab | 60 | Recruiting | NCT02600949 |
| Vaccine | Phase I | Colorectal cancer Breast cancer Head and neck squamous cell carcinoma Melanoma Non-small-cell lung cancer Pancreatic cancer Liver cancer |
— | QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001) | — | 16 | Recruiting | NCT03552718 |
| Vaccine | Phase I/II | Melanoma Colon cancer Gastrointestinal cancer Genitourinary cancer Hepatocellular cancer |
— | Messenger RNA- (mRNA-) based, personalized cancer vaccine against Neoantigens | — | 5 | Terminated (slow accrual) | NCT03480152 |
| Adoptive T-cell therapy | Phase I | Solid tumor | — | Gene-edited autologous NeoTCR-T-cells (NeoTCR-P1) | Nivolumab or IL-2 | 148 | Recruiting | NCT03970382 |
| Adoptive T-cell therapy | Phase I | Cholangiocarcinoma Colorectal carcinoma, digestive system carcinoma Esophageal carcinoma Gastric carcinoma Pancreatic adenocarcinoma |
— | CD8 + T-cells against personalized peptide antigens | Pembrolizumab | 1 | Terminated | NCT02757391 |
| Adoptive T-cell therapy | Phase I/II | Colorectal cancer | MSI | TCR-engineered T-cells against TGFBRII frameshift peptide | — | 1 | Terminated | NCT03431311 |