Table 3:
Summary of ongoing/resulted viral/bacterial vector vaccine trials for invasive HPV-associated malignancies
| Vaccine | Vector | Antigen | Disease | Study | Results |
|---|---|---|---|---|---|
| ADXS11-001 * | Listeria Monocytogenes | HPV-16 E7 | Anus (90) | Single arm phase II trial of IMRT + Mitomycin + 5-FU + ADXS11-001 | 8/9 (88.9%) patients were progression free at 42 months (NCT01671488) |
| Cervix (91) | Randomized phase II trial of ADXS11-001 +/− Cisplatin | No difference in both arms. Median overall survival of 8 months in both arms (India Trial Registry: CTRI/2010/09/001232) | |||
| Cervix (92) | Single arm phase II study in women with recurrent/metastatic or poor prognosis of ADXS11-001 | Median OS 6.1 months, (1-year OS ~ 38% vs 21% in historical controls). Median PFS 2.8 months (NCT01266460) | |||
| Cervix | Phase III: Randomized study of ADXS11-001 vs. Placebo after CCRT for definitive treatment of cervical cancer | Study closed early, results pending (NCT02853604) | |||
| HPV+ OPC** | Single arm window of opportunity neoadjuvant ADXS11-001 prior to surgery | Pending (NCT02002182) | |||
| TG4001 | Modified vaccinia (MVA) | HPV-16 E6 and E7 + IL2 | HPV+ OPC** | PhaseIb/II single arm trial of TG4001 + Avelumab in recurrent/metastatic setting | Pending (NCT03260023) |
| MG1-E6E7 | Adenovirus vector and Maraba boost | HPV16 E6 and E7 | HPV+ OPC** + Cervix | Dose escalation study with Atezolizumab | Pending (NCT03618953) |
| TheraT | LCMV and Pichinde virus vector | HPV16 E6 and E7 antigens | HPV+ OPC** | Multi-arm dose expansion trial of TheraT in combination with anti-PD-1 therapy | Pending (NCT04180215) |
| PRGN-2009 | Gorilla Adenovirus | Epitopes of HPV 16/18 E6 and E7 | HPV+ tumors | Phase I/II trial of PRGN-2009 +/− Anti-PD-L1/TGF-beta trap (M7824) in recurrent/metastatic HPV+ tumors | Pending (NCT04432597) |
*
ADXS11-001: Additional small phase I/II studies include: NCT02164461, NCT02002182, NCT02399813, NCT02291055
**
OPC: Oropharyngeal cancer