Table 2:
Summary of ongoing/resulted peptide vaccine trials for invasive HPV-associated malignancies
| Vaccine | Vector | Antigen | Disease | Study | Results |
|---|---|---|---|---|---|
| DPX-E7 | No vector | HPV16 E711-19 | HPV+ OPC*, Cervix, anus | Single arm phase I trial in relapsed/metastatic anal, cervical and HPV+ OPC* | Pending (NCT02865135) |
| ISA 101 | No vector | 12 peptides 25-35 amino acids spanning HPV-16 E6 and E7 | HPV+ OPC* | Single arm phase II trial of ISA 101 + Nivolumab in recurrent/relapsed HPV+ OPC* | Pending (NCT02426892) |
| HPV+ OPC* | Single arm Phase II of ISA 101 + Cemiplimab | Pending (NCT04398524) | |||
| HPV+ OPC* | Randomized study of Cemiplimab +/− ISA 101 | Pending (NCT03669718) | |||
| HPV+ OPC* | Single arm Phase II of ISA 101 + Utomilumab | Pending (NCT03258008) | |||
| HPV+ OPC* | IMRT + Pembrolizumab + Cisplatin + ISA 101 | Pending (NCT04369937) | |||
| Cervix | Phase I/II of ISA 101 with carbo/paclitaxel +/− bevacizumab | Pending (NCT02128126) | |||
| Cervix | Phase II Study of Cemiplimab after POD on 1st line therapy | Pending (NCT02128126) | |||
| Hespecta | No vector | HPV16 E6 conjugated to synthetic TLR2 ligand | HPV+ tumors | Phase I study of Hespecta in HPV+ tumors | Pending (NCT02821494) |
| PepCan | No Vector | HPV 16 E6 peptides | HPV+ OPC* | Phase I/II double blinded randomized study of PepCan vs placebo | Pending (NCT03821272) |
| P16_37-63 | No Vector | P16INK4a-37-63 | HPV+ tumors | Pilot study of cisplatin + P16_37-63 | Pending (NCT02526316) |
| HPV+ tumors | Phase I/IIA of P16_37-63 + Montanide ISA-51 VG in advanced HPV+ tumors | Pending (NCT01462838) | |||
| PDS0101 | No Vector | Liposomal HPV16 E6 and E7 peptides | HPV+ HNSCC | Phase II trial of pembrolizumab + PDS0101 in recurrent/metastatic HPV+ HNSCC | Pending (NCT04260126) |
| Cervix | Phase IIA trial of chemoradiation + PDS0101 in stage IB3-IVA cervical cancer | Pending (NCT04580771) | |||
| HPV+ tumors | Phase I/II trial of PDS0101 + Anti-PD-L1/TGF-beta trap (M7824) + IL12 recurrent/metastatic HPV+ tumors | Pending (NCT04287868) |
*
OPC: Oropharyngeal cancer