| 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 | Carboplatin, Docetaxel, Gemcitabine, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel, Bevacizumab |
| 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, 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. Phase II VIRO-15 trial of olvimulogene nanivacirepvec (Olvi-Vec)-primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588). SGO (2020) abstract 139 Holloway RW et al. Phase Ib study of oncolytic vaccinia virus GL-ONC1 in recurrent ovarian cancer (ROC). J Clin Oncol (2018) 36 (suppl; abstr 5577) Holloway RW et al. Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in PlatinumResistant/Refractory Ovarian Cancer. IGCS (2020) Plenary III, abstract 12 Manyam M et al. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol (2021) 163(3):481-489 |