Table 1.
Summary of clinical evaluations related to neoantigen vaccination.
| Cancer Type | ClinicalTrial.gov Identifier | Phase | Formulation | Route | Additional Intervention |
Outcome |
|---|---|---|---|---|---|---|
| Melanoma | NCT01970358 | I | Poly-ICLC (NeoVax) |
s.c. | Pembrolizumab a | 6/8 (75%) NED |
| NCT02035956 | I | Polyepitope coding RNA (IVAC MUTANOME) |
i.n. | Pembrolizumab a | 8/13 (62%) NED | |
| NCT00683670 | I | DCV | i.v. | Cyclophosphamide | Ex vivo results published [114] | |
| NCT00948480 | II | DCV | s.c. | NA | 43.4 mth m. OS 70% reduced RR (vs. TCV group) |
|
| TCV | s.c. | NA | 20.5 mth m. OS | |||
| Glioblastoma | NCT02149225 | I | Poly-ICLC (GAPVAC) | i.d. | Temozolomide | 14.2 mth m. PFS 29 mth m. OS |
| NCT02287428 | I | Poly-ICLC | s.c. | Radiotherapy | 7.6 mth m. PFS 16.8 mth m. OS |
|
| NCT00045968 | III | DCV (DCVax-L) |
i.d. | Temozolomide | 23.1 mth m. OS | |
| Ovarian cancer | NCT01132014 | I | DCV (OCDC) |
i.n. | Bevacizumab Cyclophasphamide |
13/25 (52%) SD 14 mth m. PFS |
| NCT02933073 | I | SLP (OncoImmunome) |
NA | Chemotherapy | Recruitment on-hold | |
| Advanced lung cancer | NCT02956551 | I | DCV (Neo-DCVac) |
s.c. | Cyclophosphamide | 5.5 mth m. PFS 7.9 mth m. OS |
| Metastatic renal cell carcinoma | NCT01582672 | III | DCV (Rocapuldencel-T) | i.d. | Sunitinib b | 6 mth m. PFS (vs. 7.83 mth m. PFS SOC group) 27.7 mth m. OS (vs. 32.4 mth m. OS SOC group) Terminated due to lack of efficacy |
| Solid tumors | NCT03662815 | I | SLP (iNeo-Vac-P01) |
s.c. | NA | 4.6 mth m. PFS 12-mth OS 55.1% |
| NCT02721043 | I | Poly-ICLC (PGV-001) |
i.m. | Lenalidomide | 4/12 (33%) NED 20.3 mth m. PFS |
|
| Multiple cancers | NCT02897765 | I | Poly-ICLC (NEO-PV-01) |
s.c. | Nivolumab | 23.5/8.5/5.8 mth m. PFS (MEL/NSCLC/BC) 20.7 mth m. OS (BC) |
a Administered to patients with disease reoccurrence. b Administered to patients in combination with Rocapuldencel-T, or alone as the SOC. Abbreviations: BC, bladder cancer; DCV, dendritic cell vaccine; i.d., intradermal; i.m., intramuscular; i.n., intranodal; i.v., intravenous; m., median; MEL, melanoma; NA, not applicable; NED, no evidence of disease; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression free survival; s.c., subcutaneous; TCV, tumor cell vaccines; RR, relative risk of death; SD, stable disease; SLP, synthetic long peptides; SOC, standard of care.