Table 3.
Novel/Ongoing trials concerning therapeutic vaccination.
| Intervention/ Treatment |
Primary Endpoints/Results Related to HPV-Positive Opscc | |
|---|---|---|
| NCT00257738 (phase I) [99] | Cohort 1: Peptide vaccine MAGE-A3 Cohort 2: Peptide vaccine GL-0817 |
Patients with HPV16-positive HNC, no dose-limiting toxicity was observed. 67% (4/6 patients) in the MAGE-A3 arm and 80% (4/5 patients) in the GL-0817 arm developed a T cell and antibody response. |
| ACTRN12618000140257 (phase I) [100] | DNA vaccine AMV002 | Patients with previously treated HPV-positive OPSCC, 83% (10/12 patients) developed a vaccine-induced cell-mediated response. One patient developed a greater than four-fold increase in response post-vaccine administration. |
| NCT02163057 (phase I/II) [101] | DNA vaccine MED10457 | Patients with locally advanced HPV16-positive HNC, 85% (18/21) developed a HPV-16 antigen-specific response |
| NCT03162224 (phase I/II) [102] | DNA vaccine MED10457 + durvalumab | Patients with recurrent or metastatic HPV-positive HNC, OTRR of 22.2% (6/27 patients), 3 patients had a CR, and 3 patients had a PR. |
| NCT03260023 (phase I/II) [103] | Modified Ankara vector-based vaccine TG4001 +/− avelumab | 5/9 patients with HPV-positive OPSCC, 33% (3/9 patients) with PR. |
| NCT02426892 (phase II) [106] | Peptide vaccine ISA-101 + nivolumab | 22/24 patients with HPV-positive OPSCC, OTRR 33% (8/24 patients). Cure rate in patients with HPV-positive OPSCC 9% (2/22). |
| NCT03258008 (phase II) [108] | Peptide vaccine ISA-101 + utomilumab | OTRR, Patients with HPV16-positive OPSCC. |
| NCT04369937 (phase II) [109] | Peptide vaccine ISA-101 + pembrolizumab | PFS, Patients with HPV16-positive HNC. |
| NCT0523851 (phase I/II) [110] | Liposomal peptide vaccine PDS0101 +/− pembrolizumab | Proportion of successful response, OTRR, PFS, patients with locally advanced HPV-positive OPSCC. |
| NCT04180215 (phase I/II) [111] | Live attenuated arenavirus vaccine HB-201 +/− pembrolizumab | MTD, OTRR, patients with recurrent/metastatic HPV+ HNC. |
| NCT01493154 (phase I) [112] | DNA vaccine pNGVL4a-CRT/E7 | Patients with HPV16-positive HNC. Enrolled two patients but was terminated early due to serious adverse events. |
| NCT02002182 (phase I) [113] | Live attenuated Listeria monocytogenes vaccine ADXS11-001 | Patients with HPV-positive OPSCC, preliminary results showed 55.6% (5/9 patients) had grade 3 or 4 serious adverse events |
| NCT02865135 (phase I/II) [114] | Peptide vaccine DPX-E7 | Patients with HPV-positive cancers, of which OPSCC is included. |
| NCT04432597 (phase I/II) [115] | Gorilla adenovirus vaccine PRGN-2009 | T cell infiltration response, MTD, Patients with HPV-positive cancers, of which OPSCC is included |
Key: OTRR (objective tumor response rate [complete or partial response]), CR (complete response), PR (partial response), PFS (progression-free survival), MTD (maximum tolerated dose).