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olvimulogene nanivacirepvec · 2 trials · 15 indications
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
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). |
| Single-arm run-in Olvi-Vec dose escalation Cohorts | EXPERIMENTAL | Cohort 1: Olvi-Vec administered over 3 consecutive days at 0.5,0.5,0.5 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 2: Olvi-Vec administered over 3 consecutive days at 1,1,1 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 3: Olvi-Vec administered over 4 consecutive days at 1,2,3 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. |
| Experimental Arm | EXPERIMENTAL | Olvi-Vec will be administered at the dose and schedule selected from the single-arm run-in Olvi-Vec dose escalation cohorts followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. |
| Active Comparator Arm | ACTIVE_COMPARATOR | Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR. |
| Active Comparator Arm Cross-over | OTHER | Patients randomized into the Active Comparator can cross-over to receive the same treatment as given in the Experimental Arm following determination of (1) disease progression by BICR after receiving docetaxel treatment and (2) confirming eligibility. |
| 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 |
| Platinum chemotherapy: carboplatin or cisplatin | DRUG | Administered according to local practice. |
| Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC | DRUG | Administered according to local practice. |
| Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab | DRUG | Administered according to local practice. |
| Docetaxel | 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...