Table 2.
Clinical trials in progress or results not yet reported using oncolytic viruses in high-grade glioma.
| Agent | NCT | Study Phase | n | Trial Design/Population | Outcomes (Safety, Efficacy) |
|---|---|---|---|---|---|
| G207 | NCT02457845 | Phase I | 12 | Pediatric progressive or recurrent supratentorial tumors | Safety, tolerability (AEs) PFS, OS |
| NCT03911388 | Phase I | 15 | Pediatric recurrent or refractory cerebellar tumors | Safety, tolerability (AEs) PFS, OS |
|
| HSV1716 | NCT02031965 | Phase I Terminated by sponsor |
2 | Pediatric refractory/recurrent high grade glioma | MTD, PFS, and OS up to 15 years |
| rQNestin | NCT03152318 | Phase I | 108 | Malignant glioma | MTD |
| M032 | NCT02062827 | Phase I | 36 | Recurrent malignant glioma | MTD TTP and survival up to 12 months |
| C134 | NCT03657576 | Phase I | 24 | Recurrent glioblastoma | Safety, tolerability (AEs) PFS- 3 d, 28 d, 3 M, 6 M, 12 M, OS up to 12 M |
| DNX-2401 | NCT03896568 | Phase I | 36 | Recurrent high-grade glioma | MTD, AEs Tumor response, TTP for 1 year |
| CRAd-S-pk7 | NCT03072134 | Phase I | 12 | Newly diagnosed malignant glioma | Neurological side effects, MRIs for progression |
| Toca 511 + Toca FC |
NCT02598011 (Toca 7) |
Phase Ib Terminated by sponsor |
18 | Newly diagnosed high grade glioma | DLTs |
| PVSRIPO | NCT03043391 | Phase Ib | 12 | Pediatric recurrent malignant glioma | Toxicity, 24 month OS |
| PVSRIPO + atezolizumab | NCT03973879 | Phase Ib/2 Withdrawn, resubmission expected |
_ | Recurrent malignant glioma | Safety (AEs), survival at 24 M |
| PVSRIPO + lomustine | NCT02986178 | Phase II | 122 | Recurrent malignant glioma | Objective response (iRANO) at 24 and 36 M, duration of ORR, OS at 24 and 36 M, safety (AEs) |
| REOLYSIN + GM-CSF | NCT02444546 | Phase I | 6 | Pediatric relapsed/refractory brain tumors | MTD (DLT), AE, mOS, OR, TTP |
Abbreviations: AEs = adverse events; PFS = progression free survival; mPFS = median progression free survival; OS = overall survival; mOS = median overall survival; AEs = adverse events; MTD = maximum tolerated dose; DLTs = dose limiting toxicity; ORR = objective response rate; iRANO = immunotherapy response assessment in neuro-oncology; TTP = time to progression.