CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 453 enrolled
Drug / intervention
Mirvetuximab Soravtansine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04209855
NCT04209855Phase 3Completed
CompareCT.gov

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

AbbVie·interventional·Posted Dec 24, 2019·Updated Aug 27, 2025

In Brief

A Phase 3 clinical trial evaluating Mirvetuximab Soravtansine, Paclitaxel, and 2 other interventions for Epithelial Ovarian Cancer and 2 related conditions. Completed, enrolled 453 participants across 214 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
CountriesAustralia, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsGynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT)

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 24, 2019
Enrollment StartDec 31, 2019
Primary CompletionMar 6, 2023
Study CompletionOct 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.5 years ago

Interventions

Mirvetuximab Soravtansinedrug

Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

Paclitaxeldrug

Paclitaxel will be administered per dose and schedule specified in the arm.

Topotecandrug

Topotecan will be administered per dose and schedule specified in the arm.

Pegylated liposomal doxorubicindrug

Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.