Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olaparib · 1 trial · 4 indications
Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.
| Arm | Type | Description |
|---|---|---|
| Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy | EXPERIMENTAL | IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy |
| Control Arm: SOC Chemotherapy + SOC Maintenance Therapy | ACTIVE_COMPARATOR | Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy. |
| Name | Type | Description |
|---|---|---|
| IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) | DRUG | 100 mg/m2 IP given weekly during frontline treatment |
| Paclitaxel | DRUG | 175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment |
| Carboplatin | DRUG | AUC 6 IV given every 21 days for 6 cycles during frontline treatment |
| Olaparib | DRUG | Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut. |
| Niraparib | DRUG | Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt. |
Inclusion Criteria: 1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous...