Trials / Completed
CompletedNCT04209855
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
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 453 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Detailed description
Participants will be randomized to either MIRV or IC chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirvetuximab Soravtansine | Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm. |
| DRUG | Paclitaxel | Paclitaxel will be administered per dose and schedule specified in the arm. |
| DRUG | Topotecan | Topotecan will be administered per dose and schedule specified in the arm. |
| DRUG | Pegylated liposomal doxorubicin | Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm. |
Timeline
- Start date
- 2019-12-31
- Primary completion
- 2023-03-06
- Completion
- 2024-10-29
- First posted
- 2019-12-24
- Last updated
- 2025-08-27
- Results posted
- 2024-08-01
Locations
214 sites across 21 countries: United States, Australia, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04209855. Inclusion in this directory is not an endorsement.