Table 5.
Viral therapy trials for glioblastoma.
| Trial name ClinicalTrial.gov identifier | Phase | Virus used/mode of action | Associated treatments in active arm | Control | Sample size(evaluable patients) | Median PFS(months) | MedianOS(months) | Primary endpoint | Results |
|---|---|---|---|---|---|---|---|---|---|
| NCT00390299 | I | Oncolytic carcinoembryonic antigen expressing measles virus (MV-CEA) | None | None | 23 | Ongoing | Ongoing | Safety, feasibility OS and PFS | Ongoing |
| NCT02444546 | I | Reovirus (REOLYSIN®) | Sargramostim (GM-CSF) | None | 6 | Ongoing | Ongoing | MTD and safety | Ongoing |
| NCT00528684 | I | Reovirus (REOLYSIN®) | None | None | 18 | Ongoing | Ongoing | MTD and safety | Ongoing |
| NCT00031083 | I | Adenoviral transfer of IFN-β gene | None | None | 35 | Suspended | Suspended | Safety and feasibility | Suspended |
| NCT03043391 | I | Poliovirus (PVSRIPO) | None | None | 12 | Ongoing | Ongoing | Safety, feasibility and OS24 | Ongoing |
| NCT03072134 | I | Neural stem cells loaded with adenovirus | None | None | 13 | Ongoing | Ongoing | Safety and feasibility | Ongoing |
| NCT03911388 | I | HSV G207 | +/- Single dose of 5 Gy radiation | None | 15 | Ongoing | Ongoing | Safety and feasibility | Ongoing |
| NCT01491893 (186) | I | Poliovirus (PVSRIPO) | None | Historical controls | 15 | Results pending | Results pending (interim: 12.6) | MTD, safety and feasibility | Positive |
| NCT02457845 (187) | I | HSV G207 | None | None | 5 | Results pending | Results pending | Safety and feasibility | Positive |
| D24GBM NCT01956734 |
I | Adenovirus (DNX-2401) | TMZ | None | 31 | Pending | Pending | Safety PFS6 and OS12 | Pending |
| NCT02197169 (188) | I | Adenovirus (DNX-2401) | +/- IFNγ | None | 27 | Results pending | Results pending (interim OS12 = 33 %, interim OS18 = 22 %) |
Safety and feasibility | DNX-2401 was well tolerated however the addition of IFNγ made no difference to efficacy |
| NCT03657576 | I | C134-HSV | None | None | 24 | Ongoing | Ongoing | Safety and efficacy | Ongoing |
| NCT03152318 | I | HSV (RQNestin34.5v.2) | +/- Cyclophosphamide | None | 108 | Ongoing | Ongoing | MTD | Ongoing |
| NCT02026271 (189) | I | Ad-RTS-hIL-12 | Veledimex | None | 31 | NA | 12.7 | Safety and feasibility | Positive |
| NCT03636477 | I | Ad-RTS-hIL-12 | Veledimex + Nivolumab | None | 21 | Ongoing (not recruiting) | Ongoing (not recruiting) | Safety and feasibility | Ongoing (not recruiting) |
| NCT03896568 | I | Allogenic stem cells loaded with adenovirus (DNX-2401) | None | None | 36 | Ongoing | Ongoing | Safety, feasibility and MTD | Ongoing |
| NCT03679754 | I | Ad-RTS-hIL-12 | Veledimex | None | 36 | Ongoing | Ongoing | Safety and feasibility | Ongoing |
| NCT01811992 | I | Ad-hCMV-TK and Ad-hCMV-Flt3L | None | None | 19 | Ongoing (not recruiting) | Ongoing (not recruiting) | Safety and feasibility | Ongoing (not recruiting) |
| NCT03714334 | I | DNX-2440 | None | None | 24 | Ongoing | Ongoing | Safety, feasibility and OS | Ongoing |
| NCT02031965 | I | HSV-1716 | Dexamethasone + surgery | None | 2 | Results pending | Results pending | MTD | Results pending |
| NCT02062827 | I | HSV-1 | None | None | 36 | Ongoing | Ongoing | MTD | Ongoing |
| NCT04327011 | I | Toca 511/5-FC | None | None | 65 | Terminated | Terminated | Safety and OS | Terminated |
| NCT00028158 | I/II | HSV G207 | None | None | 65 | Results pending | Results pending | Safety and feasibility | Results pending |
| NCT01301430 (190) | I/II | Parovirus H-1 (ParvOryx) | None | None | 18 | Results pending | Results pending | Safety and feasibility | Results pending |
| ONCOVIRAC NCT03294486 |
I/II | TG6002/5-FC | None | None | 78 | Ongoing | Ongoing | Safety and feasibility | Ongoing |
| NCT01582516 | I/II | Adenovirus (Delta-24-rgd) | None | None | 20 | Results pending | Results pending | Safety, feasibility and OS | Results pending |
| NCT00589875 (191) | II | AdV-tk | Valacyclovir + standard of care | Matched control cohort | 48 | 12.7 | 25.1 for patients with maximal resection | Safety, feasibility and OS | Positive |
| NCT04482933 | II | HSV G207 | Single dose of 5 Gy radiation | None | 30 | Ongoing (Not yet recruiting) | Ongoing (Not yet recruiting) | OS | Ongoing (not yet recruiting) |
| NCT02798406 | II | Adenovirus (DNX-2401) | Pembrolizumab | None | 49 | Ongoing (not recruiting) | Ongoing (not recruiting) | Objective response rate | Ongoing (not recruiting) |
| NCT00870181 (192) | II | ADV-TK | Ganciclovir + chemotherapy | None | 47 | 8.7 | 11.4 | PFS6 | Positive |
| NCT04406272 | II | VB-111 | Bevacizumab | Standard of care | 45 | Ongoing | Ongoing | TIL density and dose limiting toxicity | Ongoing |
| NCT04006119 | II | Ad-RTS-hIL-2 | Cemiplimab | None | 36 | Ongoing (not recruiting) | Ongoing (not recruiting) | Safety, feasibility and OS | Ongoing (not recruiting) |
| NCT04105374 | II/III | Toca 511/Toca FC | TMZ + radiotherapy | Standard of care | Terminated | Terminated | Terminated | PFS and OS | Terminated |
PFS, progression free survival; OS, overall survival; MTD, maximum tolerated dose.