Table 2.
Clinical trials of personalized neoantigen-based vaccines
| ClinicalTrials.gov identifier | Phase | Tumor types | Number of patients | Treatment | Form of vaccine | Status |
|---|---|---|---|---|---|---|
| NCT03359239 | I | Urothelial/Bladder Cancer | 10 | PGV001 with atezolizumab; adjuvant Poly-ICLC | Peptide | Completed |
| NCT03633110 | I/II | Melanoma, NSCLC, SCCHN, RCC or urothelial carcinoma |
24 | GEN-009 alone or combined with nivolumab or pembrolizumab; adjuvant Poly-ICLC | Peptide | Completed |
| NCT03645148 | I | Pancreatic cancer | 7 | iNeo-Vac-P01; adjuvant GM-CSF | Peptide | Completed |
| NCT02454634 | I | Grade 3 and 4 IDH1(R132H) + astrocytomas | 32 | IDH1-vac | Peptide | Completed |
| NCT01970358 | I | Stage IIIB/C or stage IVM1b high-risk melanoma | 8 | NeoVax; adjuvant Poly-ICLC | Peptide | Completed |
| NCT02897765 | Ib | Advanced melanoma, NSCLC, or bladder cancer | 82 | NEO-PV-01 plus anti-PD-1; adjuvant Poly-ICLC | Peptide | Completed |
| NCT03662815 | I | Advanced solid tumors | 22 | iNeo-Vac-P01; adjuvant GM-CSF | Peptide | Active, not recruiting |
| NCT04799431 | I | Pancreatic cancer, colorectal cancer |
12 | Vaccine and retifanlimab; adjuvant Poly-ICLC | Peptide | Not yet recruiting |
| NCT05111353 | I | Pancreas cancer | 30 | Vaccine; adjuvant Poly-ICLC | Peptide | Not yet recruiting |
| NCT04487093 | I | NSCLC | 20 | Vaccine combined with targeted drug | Peptide | Recruiting |
| NCT03122106 | I | Pancreatic cancer | 15 | Vaccine alone | DNA | Active, not recruiting |
| NCT03199040 | I | TNBC | 18 | Vaccine alone or combined with durvalumab | DNA | Active, not recruiting |
| NCT03532217 | I | Metastatic hormone-sensitive prostate cancer | 19 | Vaccine in combination with nivolumab/ipilimumab and PROSTVAC | DNA | Active, not recruiting |
| NCT03988283 | I | Pediatric recurrent brain tumor | 10 | Vaccine alone | DNA | Not yet recruiting |
| NCT04015700 | I | Glioblastoma | 12 | Vaccine alone | DNA | Recruiting |
| NCT04397003 | II | Extensive-stage small cell lung cancer | 27 | Vaccine in combination with durvalumab | DNA | Recruiting |
| NCT03480152 | I/II | Metastatic gastrointestinal cancer | 4 | mRNA-4650 | RNA | Terminated, has results |
| NCT02035956 | I | Stage III-IV melanoma | 13 | mRNA vaccine alone or combined with PD-1 blockade | RNA | Completed |
| NCT03289962 | Ib | NSCLC, colorectal cancer, melanoma, and breast cancer | 29 | RO7198457 alone or combined with atezolizumab | RNA | Active, not recruiting |
| NCT05198752 | I | Solid tumor | 36 | SW1115C3 | RNA | Not yet recruiting |
| NCT00683670 | I | Stage III melanoma | 3 | Vaccine alone | DC | Completed |
| NCT02956551 | I | Advanced lung cancer | 12 | Vaccine alone or combine with PD-1 inhibitor | DC | Unknown |
| NCT03171220 | I | Solid tumors | 6 | Vaccine alone | DC | Unknown |
| NCT03871205 | I | Lung cancer | 30 | Vaccine alone | DC | Unknown |
| NCT04912765 | II | HCC | 60 | Vaccine and nivolumab | DC | Recruiting |
GM-CSF, granulocyte macrophage colony-stimulating factor; NSCLC, non-small cell lung cancer; SCCHN, squamous cell carcinoma of the head and neck; RCC, renal cell carcinoma; TNBC, triple-negative breast cancer; HCC, hepatocellular carcinoma