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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04209855 | A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression | PHASE3 | COMPLETED | 453 | — | — | Dec 31, 2019 | Oct 29, 2024 | Aug 27, 2025 | 214 | United States, Australia +19 |
| NCT06890338 | A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. | PHASE2 | RECRUITING | 140 | — | — | Nov 21, 2025 | Feb 1, 2030 | May 29, 2026 | 64 | United States |
PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
| Arm | Type | Description |
|---|---|---|
| Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W). |
| Investigator's Choice (IC) Chemotherapy | ACTIVE_COMPARATOR | Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion. |
| Carboplatin + Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Mirvetuximab Soravtansine | DRUG | Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm. |
| Paclitaxel | DRUG | Paclitaxel will be administered per dose and schedule specified in the arm. |
| Topotecan | DRUG | Topotecan will be administered per dose and schedule specified in the arm. |
| Pegylated liposomal doxorubicin | DRUG | Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm. |
| Carboplatin | DRUG | Intravenous (IV) infusion |
| Bevacizumab | DRUG | Intravenous (IV) infusion (per investigator's discretion) |
Inclusion Criteria: 1. Female participants ≥ 18 years of age 2. Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer 3. Participants must have platinum-resistant disease: 1. Participants who have only h...