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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06915025 | Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer | PHASE3 | RECRUITING | 500 | — | — | Jul 9, 2025 | Oct 31, 2032 | Jun 2, 2026 | 7 | United States |
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...