| Trial ID # | NCT02759588; VIRO-15 |
| Phase | Ib/II |
| Drug Class | Oncolytic Viruses |
| Drug Name | Olvimulogene nanivacirepvec |
| Alternate Drug Names | light-emitting oncolytic vaccinia virus GL-ONC1, GLV-1h68, GL-ONC1 |
| Drugs in Trial | Bevacizumab, Carboplatin, Docetaxel, Gemcitabine, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel |
| Eligible Participant | Platinum resistant or platinum refractory ovarian cancer |
| Patients Enrolled | Phase I: 12 patients; Phase II: 27 patients, median 4 prior therapies (2-9); 48% Pt-R, 52% Pt-Rf |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, OS, evaluated per RECIST |
| Efficacy | Olvi-Vec alone: 12 patients, median 5 prior therapies (2-10) Olvi-Vec+CarboPt-based therapy w/ or w/o Bev: |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | Patients treated with IP Olvi-Vec-primed immunochemotherapy combined with standard carboplatinum based therapy shows ORR and PFS exceeding historical comparisons and patients’ own last prior therapy. The majority of patients benefit from apparent reversal of platinum resistance |
| Reference | Holloway RW et al. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. JAMA Oncol (2023) 9(7):903-908 |