Key clinical trials of OVVs from ClinicalTrials.gov
| Name | Genetic modifications | Enrolment | Interventions | Indication | Clinical responses | Status | NCT number |
|---|---|---|---|---|---|---|---|
| Pexa-Vec (JX-594) | Wyeth strain (ΔTK) Transgenic expression of GM-CSF and β-galactosidase | 34 | +Drug: Durvalumab (anti-PD1); Tremelimumab (anti-CTLA-4) | Colorectal cancer | Median PFS 2.3 months (PexaVec/durvalumab/tremelimumab cohorts) vs. 2.1 months (the PexaVec/durvalumab cohorts) | Phase I; Phase II | NCT0320607365 |
| 10 | Monotherapy | Melanoma | DOR and PFS were not assessable since most patients went off study within 6 weeks | Completed Phase I; Phase II | NCT00429312109 | ||
| 15 | Monotherapy | Colorectal carcinoma | PFS and OS of all eligible patients were 61 days and 10.3 months | Completed Phase II | NCT0146961163 | ||
| 23 | +Drug: Sorafenib | Carcinoma, hepatocellular | FGF-2 stimulated JX-594 activation in endothelial cells; JX-594 was able to specifically target and infect TECs | Completed Phase II | NCT01171651110 | ||
| 14 | Monotherapy | Neoplasms, liver | Median survival for all 14 patients was 9 months | Completed Phase I | NCT0062975945 | ||
| 6 | Monotherapy | Neuroblastoma | 4 of 6 patients had a SD and 2 had PD in the injected target lesion | Completed Phase I | NCT01169584111 | ||
| 30 | Monotherapy | Carcinoma, hepatocellular | Median OS 14.1 months (high dose) vs. 6.7 months (low dose) | Completed Phase II | NCT0055437267 | ||
| 129 | Monotherapy | Carcinoma, hepatocellular | Median OS 4.2 months (Pexa-Vec+BSC) vs. 4.4 months (BSC) | Completed Phase II | NCT01387555112 | ||
| 23 | Monotherapy | Melanoma | Dose-related antitumor activity was correlated with delivery and replication of JX-594 | Completed Phase I; Phase II | NCT0062545640 | ||
| GL-ONC1 (GLV-1h68) | Lister strain (ΔF14.5L, ΔA56R and ΔTK) Transgenic expression of Luc-GFP, β-glucuronidase | 64 | +Drug: Chemotherapy or bevacizumab (anti-EGFR) | Ovarian cancer | Median OS 18.5 months (platinum-resistant group) vs. 14.7 months (platinum-refractory group) | Completed Phase I; Phase II | NCT02759588113 |
| 19 | Monotherapy | Cancer of the head and neck | With median follow-up of 30 months, 1-year (2-year) PFS and OS were 74.4% (64.1%) and 84.6% (69.2%), respectively | Completed Phase I | NCT0158428469 | ||
| 9 | Monotherapy | Peritoneal carcinomatosis | GL-ONC1 was well tolerated when administered into the peritoneal cavity of patients with advanced stage peritoneal carcinomatosis | Completed Phase I; Phase II | NCT0144326068 | ||
| TroVax | Modified vaccinia virus Ankara Transgenic expression of tumor antigen 5T4 | 733 | +Drug: Sunitinib | Renal cell cancer | No significant difference in OS was evident in the two treatment arms; The magnitude of the 5T4-specific antibody response induced by vaccination with MVA-5T4 was associated with enhanced patient survival | Completed Phase II/III | NCT00397345114 |
| TG4010 | Modified vaccinia virus Ankara Transgenic expression of MUC1 and IL-2 | 222 | +Drug: First-line chemotherapy | Non-small-cell lung carcinoma | Median PFS 5.9 months (TG4010 group) vs. 5.1 months (the placebo group) | Terminated Phase II/III | NCT01383148115 |
| PROSTVAC | Wyeth strain (ΔTK) Transgenic expression of B7.1, ICAM-1, and LFA-3 | 120 | Monotherapy | Prostate cancer | PROSTVAC-VF immunotherapy was well-tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in the median OS | Completed Phase II | NCT0007858580 |
| PANVAC | Wyeth strain (ΔTK) Transgenic expression of CEA, MUC-1, B7.1, ICAM-1, and LFA3 | 48 | +Drug: Docetaxel | Breast cancer | Median PFS 7.9 months (combination group) vs. 3.9 months (control group) | Completed Phase II | NCT00179309116 |
| MVA-5T4 | Modified vaccinia virus Ankara Transgenic expression of tumor antigen 5T4 | 25 | Monotherapy | Renal cell cancer | Vaccination with MVA-5T4 did not improve ORR of IL-2 therapy, but did result in SD associated with an increase in the ratio of 5T4-specific effector-to-regulatory T cells in selected patients. | Completed Phase II | ISRCTN 83977250117 |
| rV-B7.1 | Wyeth strain (ΔTK) Transgenic expression of B7.1 | 12 | Monotherapy | Melanoma | Melanoma patients injected with rV-B7.1 develop anti-vaccinia virus antibody responses and T cell responses against defined melanoma antigens | Completed Phase I | NCT0000414879 |
| IN rVV | Copenhagen strain (ΔTK and ΔI4L) | 15 | Monotherapy | Melanoma | Of 10 remaining patients 7 showed evidence of induction of CTLs directed against at least one epitope | Completed Phase I/II | Not found117 |
PFS, progression-free survival; DOR, durability of responses; TECs, tumor-associated endothelial cells; SD, stable disease; PD, progressive disease; BSC, basic support care; ORR, objective response rates; CTLs, cytotoxic T lymphocytes. Some clinical trials without publicly available results have not been included in the table.