CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 106 enrolled
Drug / intervention
Mirvetuximab Soravtansinedrug
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/NCT04296890
NCT04296890Phase 3Completed
CompareCT.gov

SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

ImmunoGen, Inc.·interventional·Posted Mar 5, 2020·Updated Aug 7, 2024

In Brief

A Phase 3 clinical trial evaluating Mirvetuximab Soravtansine for Epithelial Ovarian Cancer and 2 related conditions. Completed, enrolled 106 participants across 89 sites in 11 countries.

Detailed Summary

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
CountriesAustralia, Belgium, Bulgaria, Czechia, Germany, Ireland, Israel, Italy, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 5, 2020
Enrollment StartJul 23, 2020
Primary CompletionNov 16, 2021
Study CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.3 years ago

Interventions

Mirvetuximab Soravtansinedrug

Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.