At a glance
ClinicalIndex Comparison Record- ✓High-grade serous (including MMMT with high-grade epithelial carcinoma), endometrioid, or clear-cell ovarian cancer that is platinum-resistant (recurrence/progression <6 months) or platinum-refractory (progression during platinum therapy), with failure of ≥2 consecutive therapies or ineligibility for additional cytotoxic therapies (except Phase 2 receiving chemotherapy).
- ✓Intermediate platinum-sensitive patients: recurrence 6-12 months after last platinum therapy, with ≥4 prior treatment regimens (≥2 platinum-based), unwilling/unable to undergo additional platinum-based cytotoxic therapy (Phase 1b only).
- ✓ECOG performance status 0 or 1 with ≥6 months life expectancy.
- ✓Measurable peritoneal disease by RECIST 1.1 (Phase 1b & 2) or non-measurable peritoneal disease confirmed by laparoscopy and/or elevated CA-125 (Phase 1b).
- ✕Mucinous or non-epithelial ovarian tumors (Brenner, sex-cord).
- ✕Unresolved bowel obstruction.
- ✕CNS metastases.
- ✕HIV seropositivity or active hepatitis infection.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1b & 2 Study With Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)
In Brief
A Phase 2 clinical trial evaluating Olvi-Vec and Platinum-doublet with or without bevacizumab for Ovarian Cancer and 2 related conditions. Completed, enrolled 46 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine if Olvi-Vec oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.
Study Details
Timeline
Interventions
Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab.