Table 5 Active trials involving oncolytic virus-based therapies

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