Table 1.
Clinical trials in vaccines targeting HPV-associated antigens.
| Identifier and Reference |
Vaccine ± Other Therapy | Phase | Type of Vaccine |
N | Target Antigens |
Population | Primary Endpoint | Status |
|---|---|---|---|---|---|---|---|---|
|
NCT00257738 Ref. [65] |
GL-0810/GL-0817 | I | Peptide | 16 | MAGE-A3 * (n = 7) /HPV16-E7 (n = 9) |
HPV16-positive or MAGE-A3-positive R/M-HNSCC |
Safety | Completed |
|
NCT02163057 Ref. [66] |
MEDI0457 | I/IIa | DNA | 22 | HPV16 E6/E7 HPV18 E6/E7 |
Advanced HPV-related HNSCC |
Safety | Completed |
|
NCT03162224 NA |
MEDI0457 + Durvalumab |
I/IIa | DNA | ±35 | HPV16 E6/E7 HPV18 E6/E7 |
R/M HNSCC HPV+ | Safety and efficacy | Completed |
|
NCT02002182 NA |
ADXS11 | II | Live (Listeria Monocytogenes) | ±15 | HPV16 E7 | Surgically elected HPV+ oropharyngeal SCC | Change in specific CD8+ CTL response and safety | Active, not recruiting |
|
NCT02291055 NA |
Durvalumab ± ADXS11 | I/II | Live (Listeria Monocytogenes) | ±66 | HPV16 E7 | R/M HPV16+ HNSCC or cervical cancer |
I: Safety II: PFS and safety |
Active, not recruiting |
|
NCT03418480 NA |
HARE-40 | I/II | RNA | ±44 | HPV16 E6/E7 | I: Advanced HPV16+ HNSCC II: Advanced HPV16+ cancer (HNSCC, anogenital, penile, cervical) |
I: Safety II: Efficacy and significant increase in specific immune cells |
Active, not recruiting |
|
NCT02426892 Ref. [76] |
ISA101 + Nivolumab | II | Peptide | 24 | HPV16 E6/E7 | Incurable HPV16+ cancers (22 oropharyngeal cancers, 1 anal cancer, and 1 cervical cancer) |
Efficacy | Active, not recruiting |
|
NCT03258008 NA |
ISA101b + Utomilumab | II | Peptide | ±27 | HPV16 E6/E7 | HPV16+ incurable oropharyngeal cancer | Efficacy | Active, not recruiting |
|
NCT02865135 NA |
DPX-E7 | Ib/II | Peptide | ±11 | HPV16 E7 | Positive HLA-A*02 patients with HPV-related head and neck, cervical or anal cancer. | Safety | Active, not recruiting |
|
NCT03260023 NA |
TG4001 + Avelumab | Ib/II | Live (modified vaccinia Ankara virus) | ±52 | HPV16 E6/E7 | HPV-related carcinomas |
I: Safety II: Efficacy |
Recruiting |
|
NCT02526316 NA |
p16 vaccine + concurrent cisplatin-based chemotherapy | I | Peptide | ±11 | p16 | p16-positive cervical, vulvar, vaginal, penile, anal, or head and neck cancer | Immune response | Completed |
|
NCT01462838 Ref. [75] |
p16 vaccine | I/IIa | Peptide | 24 | p16 | HPV-associated cancers (including 6 HNSCC) | Immune response | Completed |
|
NCT04260126 NA |
PDS0101 + Pembrolizumab | II | Peptide | ±96 | HPV16 E6/E7 | HPV16+ R/M HNSCC and HPV-related esophageal SCC | Efficacy | Recruiting |
|
NCT04369937 NA |
ISA101b + Pembrolizumab + Cisplatin + radiotherapy | II | Peptide | ±50 | HPV16 E6/E7 | “Intermediate risk” HPV-16 associated HNSCC | Efficacy | Recruiting |
|
NCT04534205 NA |
BNT113 + Pembrolizumab vs. Pembrolizumab alone | II | RNA | 285 | HPV16 E6/E7 | HPV16 + and PD-L1+ R/M HNSCC | Part A: Safety Part B: Efficacy |
Recruiting |
|
NCT04287868 Ref. [73] |
PDS0101 + M9241 + M7824 | I/II | Peptide | 21 | HPV16 E6/E7 | Advanced HPV16-positive cancers | Objective Response Rate | Suspended |
|
NCT04180215 Ref. [74] |
HB-201 ± HB-202 | I/II | Virus | ±200 | HPV16 E6/E7 | HPV16-positive cancers | I: dose-limiting toxicities II: ORR |
Recruiting |
|
NCT04672980 NA |
RTX-231 | I | Allogenic aAPC | ±63 | HPV16 E7 | Advanced HPV16 positive cancers | I: safety | Recruiting |
aAPC: artificial antigen-presenting cells; HPV: human papillomavirus; R/M: recurrent or metastatic; NA: not available; PFS: progression-free survival; HNSCC: head and neck squamous cell carcinoma. * MAGE-A3 is not a specific HPV-associated antigen.