Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05281471 | Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) | PHASE3 | RECRUITING | 186 | — | — | Aug 31, 2022 | Oct 1, 2026 | Mar 18, 2026 | 31 | United States |
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Olvi-Vec + Platinum-doublet & bevacizumab | EXPERIMENTAL | Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0 Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5 |
| Physician's Choice of Chemotherapy & bevacizumab | ACTIVE_COMPARATOR | Physician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent). |
| Name | Type | Description |
|---|---|---|
| olvimulogene nanivacirepvec | BIOLOGICAL | Olvi-Vec is an engineered oncolytic vaccinia virus |
| Platinum chemotherapy: carboplatin (preferred) or cisplatin | DRUG | Administered according to local practice |
| Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin | DRUG | Administered according to local practice |
| Bevacizumab (or biosimilar) | DRUG | Administered according to local practice |
Inclusion Criteria: * Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer. * High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed...