Table 8.
Clinical trials of vaccines for metastatic urothelial carcinoma.
| Regimen | Drug Classes | Target | Inclusion Criteria | Phase | Status (March 2023) |
Identifier | ORR | mPFS (Months) |
mOS (Months) |
|---|---|---|---|---|---|---|---|---|---|
| PGV001 + atezolizumab | Personalized tumor neoantigen vaccine + anti-PDL1 | mUC | 1 | Completed | NCT03359239 | NA | NA | NA | |
| CV301 + atezolizumab | Poxviruses encoding CEA, MUC-1 + anti-PDL1 | CEA, MUC-1 | mUC | 2 | Completed | NCT03628716 | 9.4% | NA | NA |
| INO-5401 + INO-9012 + atezolizumab | Plasmids encoding WT1, PSMA, hTERT, IL12 + anti-PDL1 | WT1, PSMA, hTERT | mUC | 1/2a | Active, not recruiting | NCT03502785 | NA | NA | NA |
| Chimerical exosomal tumor vaccine | Exosomes in supernatant of chimeric APC-tumor cells | mUC | 1 | Recruiting | NCT05559177 | NA | NA | NA | |
| NEO-PV-01 + nivolumab | Personalized tumor neoantigen mRNA vaccine + anti-PD1 | mUC, NSCLC, melanoma | 1b | Completed | NCT02897765 | 27% | 5.8 | 20.7 | |
| NeoPepVac EVAX-01-CAF09b + anti-PD1/PDL1 | Personalized tumor neoantigen vaccine | mUC, NSCLC, melanoma | 1/2 | Active, not recruiting | NCT03715985 | NA | NA | NA | |
| IO102-IO103 + pembrolizumab | IDO + PD-L1 peptide vaccine + anti-PD1 | IDO, PD-L1 | 1L mUC, NSCLC, SCCHN | 2 | Recruiting | NCT05077709 | NA | NA | NA |
| OH2 | Oncolytic virus delivering GM-CSF gene | mUC | 2 | Recruiting | NCT05248789 | NA | NA | NA |
Abbreviations: ORR = objective response rate; mPFS = median progression-free survival; mOS = median overall survival; mUC = metastatic urothelial carcinoma; mRNA = messenger RNA; NA = not available; GM-CSF = granulocyte-macrophage colony-stimulating factor.