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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05445778 | Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 520 | — | — | Mar 15, 2023 | May 1, 2032 | Jun 2, 2026 | 264 | United States, Argentina +20 |
| NCT07059845 | A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer | PHASE2 | RECRUITING | 400 | — | — | Nov 13, 2025 | Jan 1, 2029 | Jun 4, 2026 | 71 | United States, Australia +5 |
| NCT05041257 | Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers | PHASE2 | COMPLETED | 79 | — | — | Oct 19, 2021 | Dec 12, 2024 | Jan 9, 2026 | 35 | United States, Australia +5 |
Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Mirvetuximab Soravtansine (MIRV) plus Bevacizumab |
| Arm 2 | ACTIVE_COMPARATOR | Bevacizumab monotherapy |
| Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration. |
| Substudy 1 Arm B: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration. |
| Substudy 1 Arm C: Bev | EXPERIMENTAL | Participants will receive Bev, as part of the approximately 40 month study duration. |
| Substudy 2 Arm D: MIRV Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration. |
| Substudy 2 Arm E: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration. |
| Substudy 3 Arm F: MIRV Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with BEV and carboplatin, followed by MIRV at a lower dose with BEV, as part of the approximately 31 month study duration. |
| Substudy 3 Arm G: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with BEV and carboplatin, followed by MIRV at the same dose with BEV, as part of the approximately 31 month study duration. |
| Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW) |
| Name | Type | Description |
|---|---|---|
| Mirvetuximab soravtansine plus Bevacizumab | DRUG | Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks |
| Bevacizumab | DRUG | Participants will receive Bevacizumab 15mg/kg every 3 weeks |
| Mirvetuximab Soravtansine | DRUG | Intravenous (IV) infusion |
| Carboplatin | DRUG | IV Infusion |
Inclusion Criteria: 1. Adult women \>/=18 years old 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1) 4. Relapsed disease after frontline (first-line) ...