Table 5.
Active trials involving oncolytic virus-based therapies
| NCT | Phase | Intervention | Target population | Location | Sample size | Key outcomes |
|---|---|---|---|---|---|---|
| NCT00634231 | Phase I | AdV-tk (oncolytic adenovirus) intratumorally plus valacyclovir immediately after resection | High-grade glioma or recurrent ependymoma in children | USA | 8 | Safety, adverse events, OS, PFS, immune response |
| NCT02062827 | Phase I | M032 (oncolytic HSV-1) delivered intratumorally via MRI-guided infusion | Recurrent high-grade glioma | USA | 24 | MTD, PFS, OS |
| NCT02457845 | Phase I | G207 (oncolytic HSV-1) with RT intratumorally | Progressive high-grade brain tumors in children | USA | 12 | Safety, adverse events, immunologic response, virologic shedding, PFS, OS |
| NCT02798406 | Phase II | DNX-2401 (oncolytic adenovirus) delivered intratumorally; with combination pembrolizumab | Recurrent glioblastoma or gliosarcoma | USA | 49 | ORR, OS, duration of response |
| NCT03072134 | Phase I | NSC-CRAd-Survivin-pk7 (neural stem cells loaded with oncolytic adenovirus) delivered intratumorally after resection | Newly diagnosed high-grade glioma | USA | 13 | MTD, MRI evaluation of tumor response |
| NCT03152318 | Phase I | rQNestin34.5v.2 (oncolytic HSV-1) given intratumorally after biopsy; cyclophosphamide given preop | Recurrent high-grade glioma | USA | 56 | MTD, MRI changes, viral shedding, viremia, HSV1 antibody response |
| NCT03576612 | Phase I | AdV-tk (oncolytic adenovirus) intratumorally plus nivolumab plus oral valacyclovir and TMZ/RT | Newly diagnosed high-grade glioma | USA | 36 | Adverse events, OS, PFS, immune profiling, cytokine profiles |
| NCT03636477 | Phase I | Intratumoral Ad-RTS-hIL-12 (adenovirus encoding human IL-12) after resection, veledimex (IL-12 immunotherapeutic activator), and nivolumab | Recurrent glioblastoma | USA | 21 | Safety, tolerability, ORR, PFS, OS, pharmacokinetics |
| NCT03657576 | Phase I | Dose escalation and safety trial of genetically engineered HSV C134 | Recurrent high-grade glioma | USA | 24 | Adverse events, PFS, OS, HSV titer, WBC composition |
| NCT03714334 | Phase I | Intratumoral injection of DNX-2440 (oncolytic adenovirus) | Recurrent glioblastoma or gliosarcoma | Spain | 24 | Adverse events, OS, ORR |
| NCT03911388 | Phase I | G207 (oncolytic HSV-1) delivered intratumorally, postoperative RT | Recurrent posterior fossa brain tumors in children | USA | 15 | Safety, tolerability, immunologic response, viral shedding, PFS, OS |
| NCT04006119 | Phase II | Ad-RTS-hIL-12 (adenovirus encoding human IL-12), veledimex (IL-12 immunotherapeutic activator), and cemiplimab (anti-PD-1) | Recurrent glioblastoma | USA | 40 | Safety and tolerability, OS, PFS, ORR, immune responses |
| NCT04406272 | Phase II | VB-111 (oncolytic adenovirus) intravenously preop and intraop, vs placebo groups, with bevacizumab | Recurrent glioblastoma | USA | 45 | TIL density, DLT, PFS, OS |
| NCT04479241 | Phase II | Intratumoral PVSRIPO (poliovirus) followed by IV pembrolizumab | Recurrent glioblastoma | USA | 30 | ORR, duration of response, adverse events, OS, PFS, biomarker evaluation |
| NCT04482933 | Phase II | Intratumoral G207 (HSV-1) with postoperative RT | Recurrent high-grade glioma in children | USA | 30 | OS, adverse events, virologic shedding, immune responses |